Stereotactic soft tissue coring biopsy devices and methods

ABSTRACT

An excisional device for either handheld car stereotactic table use may comprise an outer sheath that may comprise a distal scoopula shape configured to penetrate and/or cut tissue independently or in concert with work element(s). The articulable work element(s) may comprise articulable beak(s) and may be configured to translate and/or rotate at a first rate and to cut tissue in a direction implied by placement of the scoopula shaped outer sheath. A first helical element or equivalent assembly may be configured to transport tissue cut by the work element(s) and/or scoopula, may be co-axially disposed relative to the work element(s) and may be operative to rotate at a second rotation rate that is different than the first rate. A proximal sheath may be co-axially disposed relative to the work element(s) and the first helical element, and may be configured to rotate and actuate the work element(s).

BACKGROUND

Embodiments relate to medical devices and methods. More particularly,embodiments relate to stereotactic table mounted or hand-held singleinsertion, multiple sample soft tissue excisional biopsy and coringdevices and corresponding methods for retrieving multiple soil tissuebiopsy samples using a single insertion.

SUMMARY

Embodiments are drawn to medical devices and methods that are used forcore biopsy procedures. According to one embodiment, a biopsycoring/delivery device, also referred to herein as an excisional device,may be configured to retrieve multiple samples of normal and/or abnormalappearing tissues during a single insertion through the skin(percutaneous procedure). Embodiments may comprise structures andfunctionality for different phases of a multi-phase biopsy procedure,which may be performed by hand or through attachment to a stereotactictable or Magnetic Resonance Imaging (MRI) stage. For example,embodiments may comprise a pre-treatment of the area and/or of theabnormal tissue, or the delivery of tracer materials for tracking thepotential spread or flow patterns of abnormal tissues (such as canceroustissues) through the process of metastasis. Embodiments may alsocomprise an infra-procedure delivery of medications that may anesthetizetissues at the site, or that may deliver other therapeutic agents suchas, for example, pro-coagulants. Embodiments may also be configured forthe delivery of post-procedure materials such as medications,implantable materials for cosmetic purposes, marking elements and otherimplantable elements for later imaging reference, or other purposes.Embodiments may also be configured for imaging of the surroundingtissues during preoperative, intra-operative, and/or post-operativephases of the device's clinical use. Embodiments may also be configuredto allow for ablation of tissue during pre-, intra-, and/orpost-operative phases. Embodiments of the biopsy device, along withassociated related subcomponents described herein, may be configured toretrieve solid, contiguous and/or fragmented tissues as well as liquidand semi-solid tissues for analysis, diagnosis and treatment.Embodiments may be portable, disposable or reusable and may beelectrically, mechanically and/or manually powered and operated.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a core biopsy device according to oneembodiment;

FIG. 2 is a perspective view of a movable, rotatable scoopula-shapedouter sheath with a movable, rotatable cutting element and transport,helix attached, according to one embodiment;

FIG. 3 is a side view of an outer sheath and articulated beak andhelical element, according to one embodiment;

FIG. 4 is a side view of an outer sheath and a rotating inner beak andhelical element, according to one embodiment;

FIG. 5 is an overhead view of a beak element with living hinge closingagainst a scoopula-shaped outer sheath, according to one embodiment;

FIG. 6 is a side view of an outer sheath and inner cutting element andhelical element according to one embodiment;

FIG. 7 is a side view of an outer sheath and cutting element, accordingto one embodiment;

FIG. 8 is a side view of another embodiment of an articulated beak andattachment mechanism, according to one embodiment;

FIG. 9 is a side view of the working elements of FIG. 8, in open beakconfiguration, according to one embodiment;

FIG. 10 is a side view of the rotating inner cutting element and outerrotatable scoopula-shaped element; according to one embodiment;

FIG. 11 is a side view of another embodiment of an outer sheath andinner cutting element;

FIG. 12 is a top view of an outer sheath and cutting element aligned atits distal tip, according to one embodiment;

FIG. 13 is an end on perspective view of an outer sheath mid innercutting element in over center open configuration, according to oneembodiment;

FIG. 14A is an end on perspective view of an outer sheath and innercutting element in rotated position, according to one embodiment;

FIG. 14B is an end on perspective view of an outer sheath and innercutting element in further rotated position, according to oneembodiment;

FIG. 15A is a perspective view of a split-tube single beak assembly inretracted position against an outer sheath with scoopula, according toone embodiment;

FIG. 15B is a perspective view of a split-tube single beak assemblyextending part way out of an outer sheath, with the beak open overcenter, according to one embodiment;

FIG. 15C is a perspective view of a split-tube single beak assembly infolly extended position at the end of the scoopula of an outer sheathfor part off of a tissue specimen and for other purposes, according toone embodiment;

FIG. 16A shows details of a work element according to one embodiment;

FIG. 16B show details of a work element and outer sheath of anexcisional device according to one embodiment;

FIG. 17A shows an element of an excisional device according to oneembodiment;

FIG. 17B shows a detail of an element of an excisional device, accordingto one embodiment;

FIG. 18 shows a proximal sheath comprising a plurality of elongatedslots disposed in a spiral pattern around a longitudinal axis, accordingto one embodiment;

FIG. 19 shows details of a proximal sheath, beak actuation elements andinner helical element of an excisional device according to oneembodiment;

FIG. 20 shows an outer differentially rotating or rotatable outersheath, which may function as a true outer sheath including an open butnon-scoopula shaped extremity or as a distal sheath of an excisionaldevice according to embodiments;

FIG. 21 is a view of a twin beak work assembly of an excisional devicewith the distal sheath and outer sheath removed, according to oneembodiment;

FIG. 22 is a view of a single beak work assembly of an excisional devicewith the oater sheath, distal, sheath and proximal sheath removed,according to one embodiment;

FIG. 23 shows a top view of a mechanical arrangement for cutting elementrotation and actuation, according to one embodiment;

FIG. 24 is an illustration of a cam and earn follower arrangement,according to one embodiment;

FIG. 25 is a side view of a cutting element actuation mechanism,according to one embodiment;

FIG. 26A is a side view of the internal and external features of abiopsy device according to one embodiment;

FIG. 26B is a front end-on view of the shape of a biopsy device,according to one embodiment;

FIG. 26C is a perspective view of a transfer magazine, according to oneembodiment;

FIG. 26D is a cross sectional view of a transfer magazine according toone embodiment, taken along line AA′ of FIG. 26C;

FIG. 26E is a perspective view of a hinged, clamshell embodiment of atransfer magazine, according to one embodiment;

FIG. 27A is a first view of a stereotactic table adapter for a biopsydevice, according to one embodiment.

FIG. 27B is a second view of a stereotactic adapter for a biopsy device,according to one embodiment.

FIG. 27C is a side view of an adapter platform, suitable for astereotactic table stage, and on which an excisional device may becoupled, according to one embodiment.

FIG. 28A is a perspective exploded view of a capstan assembly, accordingto one embodiment.

FIG. 28B is a top view of a capstan assembly, according to oneembodiment.

FIG. 28C is a top view of a capstan assembly in a first configuration,according to one embodiment.

FIG. 28D is a top view of a capstan assembly in a second configuration,according to one embodiment.

FIG. 29A shows structure of an element of an excisional device accordingto one embodiment.

FIG. 29B shows structure of an additional element of an excisionaldevice according to one embodiment.

FIG. 29C shows still more structure of an element of an excisionaldevice according to one embodiment.

FIG. 29D shows further structure of an excisional device according toone embodiment.

FIG. 30A shows a monolithic beak assembly of an excisional deviceaccording to one embodiment.

FIG. 30B shows a detail of a proximal end of a monolithic beak assemblyof an excisional device according to one embodiment.

FIG. 31 shows the distal end of a proximal sheath of an excisionaldevice according to one embodiment.

FIG. 32 shows an assembly comprising the monolithic beak assembly andthe proximal sheath of an excisional device according to one embodiment.

FIG. 33 shows the distal end of a distal, sheath of an excisionaldevice, according to one embodiment.

FIG. 34 shows an assembly comprising a monolithic beak assembly, aproximal sheath and a distal sheath, according to one embodiment.

FIG. 35 shows the distal portion of an excisional device according toone embodiment.

FIG. 36 is a flowchart of a method according to one embodiment.

FIG. 37 is a flowchart of a method of positioning a biopsy device,according to one embodiment.

FIG. 38 is a flowchart of another method according to one embodiment.

DETAILED DESCRIPTION

Reference will now be made in detail to the construction and operationof embodiments illustrated in the accompanying drawings. The followingdescription is only exemplary of the embodiments described and shownherein. The embodiments, therefore, are not limited to theseimplementations, but may be realized by other implementations.

Core biopsy procedures have evolved from simple core needle biopsiescomprising aspiration of fluids using a simple syringe and needle todevices having the capability to extract solid tissues forhistopathological analysis. This more recent capability has proved to bea far more powerful way to diagnose diseases and abnormal tissueentities, some of which are extremely life threatening, and others,which may be more benign but nevertheless must be definitivelydistinguished from the more dangerous types of abnormalities, includingpre-cancerous lesions, in-situ cancers, invasive cancers, and otherspace occupying lesions such as cystic lesions, serious infections andothers. As core biopsy procedures have evolved into far morediagnostic-ally powerful tools, they have displaced many of the moreinvasive open surgical procedures which, however, continue to beperformed for diagnostic purposes based on the advantages of retrievinga sufficient volume of tissue with the preserved architecture that is soimportant in the diagnosis and treatment algorithm used by clinicians inaddressing these abnormalities and diseases. One of the basic needsduring a biopsy procedure is to accurately correlate tissue diagnoseswife imaging diagnoses. In order to successfully accomplish this, it isimportant to know that, the retrieved tissue actually and accuratelyrepresents the imaged abnormality. This is an aspect, where many coringbiopsy devices fall short. It is for this reason that open surgicaldiagnostic procedures and other invasive procedures continue to beperformed. Other clinically significant limitations of core biopsyprocedures include the manner in which the abnormal tissue is separatedfrom the host organ, the manner in which the tissue is retrieved andhandled during the procedure by the coring biopsy device, and the amountof biopsy artifact/damage imparted to the tissue specimens by the coringprocedure and device. It is well known that the larger the caliber ofthe retrieved tissue samples, the better the correlation with theimaging abnormality, and thus the easier and more accurate, definitiveand helpful the diagnosis. However, in order to retrieve larger caliberspecimens, most biopsy devices have large outer diameters, leading toincreased complications, pain and other adverse effects, due principallyto the greater trauma associated with the larger bore devices. Movingthese larger bore devices through the tissues is much more difficult,particularly without the help of an active mechanism to aid in smootherand more gradual advancement of the biopsy device. Additionally, thelarger the caliber of the biopsy device, the more difficult it becomesto precisely visualize the biopsy device in relation to the targetabnormality, especially for small lesions (on the order of about ½ cm toless than ¼ cm). Despite these limitations, more than 4-5 milliondiagnostic core biopsies are performed each year around the world in thebreast alone, with as many as 2 million diagnostic breast biopsies beingperformed each year in the US. There is little doubt that many invasive,open surgical diagnostic biopsies should be replaced by improved corebiopsy procedures.

Reference will now be made in detail to the construction and operationof embodiments illustrated in the accompanying drawings. FIG. 1 shows abiopsy or, more generally, an excisional device 10 according toembodiments. The excisional biopsy device 10 may comprise a tubularcoring and transport assembly 11 that may, according to one embodiment,have a distal end defining a scoopula shape. The distal end may have ashape that differs from the scoopula shape and that differs from, thatshown in the figures. The scoopula forms part of an outer sheath (alsocalled “outer tube,” or “non-rotating outer sheath,” or “differentiallyrotating outer sheath,” or “manually rotating outer sheath”) ofappropriate dimensions to retrieve a single or multiple core samples oftissue (not shown) that is/are sufficient to provide the desiredclinical diagnostic or therapeutic result. The scoopula may be made ofmaterials, or include coatings, that, may enhance penetration and/orhemostasis, and may also be configured to include external features thatenhance penetration and/or stabilization within the tissue, for example,spirally-disposed ridges and/or grooves, as well as features such asaxial slits to enhance visibility under guidance modalities such asultrasound. Such, an appropriate dimension may be, for example, about 4inches in length, in addition to a forward excursion of the tubularcoring and transport assembly 11 during the coring phase. It is to beunderstood, however, that the foregoing dimensions and any dimensionsreferred to herein are exemplary in nature only. Those of skill in thisart will recognize that, other dimensions and/or configurations may beimplemented, depending upon the application, and that the tubular coringand transport assembly 11 and its subparts, as well as other elements ofthe device, could be of any length or dimension, all of which areconsidered within the scope of this disclosure. Furthermore, anydiscussion of dimensions or ranges of dimensions or physical or dynamicaspects such as flow rates or ranges of motion or time factors outlinedherein are exemplary in nature only and should not be considered to belimiting. The outer sheath may be removable such that, according to oneembodiment, such outer sheath may be fully detached from the biopsydevice 10 and thus be temporarily placed or left in place in the body toenable delivery through its lumen of substances or other devices duringpre-operative, biopsy, and/or post-operative phases.

One embodiment of the biopsy device 10, as shown in the figures, may beconfigured for hand-held operation and may comprise an ergonomicallycomfortable and secure handle 12 at its proximal end from which thetubular coring and transport, assembly 11 extends so that the biopsydevice 10 may be easily directed with one hand while the other hand isfree to hold a guiding probe such as an ultrasound transducer. However,it is to be understood that embodiments may readily be configured to fitonto any number of guiding devices such as a stereotactic table imagingstage or equipment associated with other guidance modalities such asMagnetic Resonance Imaging (MRI) (not shown). As shown, one embodimentof the biopsy device 10 may comprise one or more sharp, rotating ornon-rotating cutting elements 13 (herein, alternatively and collectivelyreferred to as “cutting element,” “work element,” “beak,” “beakassembly,” articulable beak,” or “beak element” or “beak elements”)projecting forward from the distal free end of the removable tubularcoring and transport assembly 11. According to one embodiment, the (oneor more) cutting element 13 may travel distally up to the end of adistal scoopula for the purposes of forward, penetration, coring and/orparting off of the core sample in a combined forward cutting and sidecutting motion in reference to the scoopula. Such a scoopula itself maybe composed of one or more elements, such as a series of small forwardprojections, which in the aggregate have the form of a scoopula. Theremay also be more than one scoopula extending from the tubular coring andtransport assembly, and these may be of different shapes to each other.The tubular coring and transport assembly 11 may comprise a plurality ofcomponents, which plurality may be configured to transmit rotationalmovement and opening/closing actions to the rotating or non-rotatingcutting beak elements 13. It is to be understood that the “tubular”description of the coring and transport assembly 11 expresslyencompasses any cross sectional shape and size, of any length and may inaddition be flexible, as for example, to navigate through vascularspaces or around sensitive structures within soft tissues. If is furtherto be understood that the tens non-rotating also includes other cuttingactions such as axially aligned, fore and aft movements of cutterelements, which may be powered or manually actuated. Such actions mayconsist of slow “jack-hammering” movements alone or in combination withrotation, or may include high frequency motions such as ultrasonicvibrations. Cutting may also be earned out alone or in combination withthese motions and/or rotation (rotation including continuous in onedirection, cyclic reversing or in oscillation) by energizing cuttingsurfaces, with modalities or combinations of modalities such as laser,radiofrequency, microwave, heat and chemical among others. Embodimentsinclude tailoring of excursion of fore and aft and/or rotationalmovements such that they may be configured to preferentially cut/corespecific tissues. For example, shorter frequently repetitious excursionscould preferentially sever hard tissue leaving soft tissue intact whilelonger excursions that exceed certain soft tissue elastic limits couldbias cutting towards more effective soft tissue severing. The componentsand features of the tubular coring and transport assembly 11 may also beconfigured to transfer the core sample(s) back proximally along theinternal length of an inner lumen defined within the tubular coring andtransport assembly 11 to the handle 12 and to the transfer compartmentor magazine 27.

According to one embodiment thereof, the biopsy device 10 may comprise ahandle 12, which handle 12 may comprise and/or be coupled to mechanicalcomponents (not shown in this figure) configured to drive the distaltabular coring and transport assembly 11 to enable it to discharge itscoring, transport, part-off and delivery functions. As shown, oneembodiment may comprise a distally-disposed beak, element 13 that maycomprise one or more sharp cutting tip blades configured, together witha distal scoopula portion of an outer sheath, to penetrate tissue to thetarget site of the intended biopsy, core the target biological tissueand part-off or cut off the core sample (not shown) at the end of thescoopula or beyond, or at any desired point along the length of thescoopula of the outer sheath. The ability of the present biopsy deviceto repeatedly core and retrieve multiple samples (not shown) during asingle insertion and then accumulate the cored samples in a transfermagazine 27 means that with a single penetration through the skin of,for example, a human breast, the operator can sample multiple areaswithout causing additional trauma that would otherwise be associated byrepeatedly removing the biopsy device 10 each time a sample is taken,and reintroducing the biopsy device 10 back into the patient to takeadditional core samples. The handle 12 may also comprise and/or becoupled to (internal or external) mechanical components (not shown) andfeatures for vacuum-assisted fluid evacuation as well as componentsconfigured for the delivery of materials such as, for example, a varietyof medications, tracer materials, implantable elements, marker elementsand diagnostic and therapeutic devices. Hie tubular coring and transportassembly 11, according to one embodiment, may be configured such as tocreate the smallest possible caliber (e.g., outside diameter) of coringtube (tubular coring and transport assembly 11) with a range of (forexample) about hypotube 16 gauge to about 8 gauge diameter, whileproviding a sufficiently large diameter of core sample obtained to beclinically useful. The tubular coring and transport assembly 11 may alsobe constructed of flexible materials and be of a sufficient length toreach target sites distant from the skin surface without the need for anopen surgical procedure to enable the distal end (that end thereof thatis furthest from the handle 12) of the biopsy device 10 to reach thetargeted site. In the embodiment of FIG. 1, the distal tubular coringand transport assembly 11 of the biopsy device 10 may extend distallyfrom the handle 12 and be configured to provide a distance sufficient tocreate a core of sufficient length for diagnosis and/or treatmentpurposes. As is described below, this distance of forward or distalprojection may be selectively changed at will, thanks to structureconfigured for that purpose, which may be built into or otherwisecoupled to the present biopsy device 10.

Embodiments of the present biopsy device 10 may be used by right and/orleft handed persons and in multiple positions and orientations, so thatin areas of limited access, the present biopsy device may still beeasily positioned for ideal orientation to perform a biopsy procedureraider real-time or other image guidance modality. The entire device maybe configured to be disposable or may be configured to be reusable inwhole or in part. Embodiments of the present biopsy device 10 may beelectrically powered by one or more batteries and/or external powersources through, a simple electrical coupling to connect to an externalpower supply conveniently placed, for example, in the handle or proximalend of the present biopsy device as shown at element 637. The entiredevice may also be internally or externally manually powered,mechanically powered or be powered by means such as compressed air, gasor pressurized fluid. Powering the excisional device entirelymechanically may be advantageous in areas in which the electric grid isabsent unavailable, or unreliable. In FIG. 1, the biopsy device 10 isshown in a pre-coring configuration with the scoopula-shaped distal endthereof open and in a configuration in which it partially projectsforward from the proximal handle 12 from its resting position with aportion of the beak element 13 extending slightly distally in closedconfiguration along the first part of its forward excursion. In thisview, the biopsy device 10 is shown with, various illustrative switchesto activate and/or physically move various internal components (notshown).

One embodiment is a method of carrying out a breast biopsy. Such amethod may comprise imaging the tissue of the organ (the breast, in thisexample) of interest and identifying the target lesion(s) or tissue tobe removed or biopsied. The skin may then be cleaned using steriletechniques, the patient may be draped and anesthetics may be delivered.In the case wherein the present biopsy device is configured forstereotactic operation, the present biopsy device may be mounted to thestage of a stereotactic table. The stage is used to fix the position ofthe biopsy instrument, which may be electronically registered andrendered on a screen. The generated electronic data may be used toposition the device within the patient, under computer assistance. Thecoordinates of the target lesion from the initial images may be recordedin x, y and z axes. Thereafter, once the biopsy device is attached,those dimensions are automatically keyed into the system and x, y and zaxes are then calculated to aim the biopsy device (manually entered intothe adjusting wheels of the stage) and the stage is cocked for firingor, according to embodiments, the internal firing mechanism of thedevice 10 is used in place of or in addition to the stereotactic tablestage firing mechanism. Once the biopsy device is in place (afterfiring), a new set of images are taken with X-ray and the new targetcoordinates (if changed) are entered. If the biopsy device appears wellplaced, biopsies are generally taken “about the clock face”, accordingto one embodiment. Herein, “about the clock face” generally means in6-12 spaced positions around the clock face (i.e. 6 to 12 samples over a360 degree sweep around the initial biopsy penetration axis). If shortsamples (shorter than the length of the scoopula, for instance) aredesired, the operator may manually part off the core sample at anylength along the forward movement of the cutting elements and continueto core forward or reset the coring assembly at its most rear-wardposition for further full length or short coring procedures. Once ailcore samples are taken, the device may then be backed out with the stagecontrols (manually) and a post-procedure set of X-ray images may betaken to determine whether the target was partially or fully removed.Next, a photographic record may be taken of the samples is the transfermagazine and/or a post procedure set of X-ray images may be taken of theremoved samples to determine whether markers of the lesion(micro-calcifications in this instance) are present in the retrievedsamples. Lastly, a post procedure clip or marker may be placed in thebiopsy site area, to mark the location of the biopsy to enable a laterprecise identification of the location of the biopsy and the wound maybe dressed and bandaged.

In more detail and according to one embodiment, once the present biopsydevice has been fixed to the stereotactic table stage, the distal tip ofthe biopsy device may be introduced through a nick/incision in thepatient's skin. The present biopsy device may then be maneuvered intothe desired position, using one of the penetration modes of the device.Once the distal end of the device is in close proximity to and alignedwith the target lesion, a further penetration mode of the present biopsydevice may be activated, either with the stereotactic table's own firingmechanism or the depth controllable firing mechanism built into thepresent biopsy device or both, according to embodiments. Suchembodiments may specify that only the outer sheath and incorporatedscoopula are actually fired through the lesion or the entire tubularcoring and transport assembly may be fired forward together with theouter sheath and scoopula. In one embodiment, the scoopula may be firedto a specified distance less than its full travel capabilities. Itshould be noted that the scoopula and any other elements, for example, aguide, may be fired independently of any other element. In any of thesepenetration modes, or in otherwise maneuvering the device, thescoopula-shaped distal end of the outer sheath of the biopsy device maybe placed in proximity to or through the target lesion. Alternatively,the removable outer sheath may be similarly placed by itself through anick in the patient's skin to a position in proximity to or through, thetarget lesion, with or without a jig or fixture or holding device to fixit to the stereotactic table stage or manually, at which point anoptional delivery stage may then be initiated to deliver, for example,the contents of a preloaded cartridge comprising, for example, tracerelements such as visible dyes, echo-enhancing materials and/orradioactive tracer elements. After or instead of such an optionaldelivery stage, the device 10 may be connected to the previously placedremovable outer sheath in order to deliver biologically-activesubstances such as medications (such as epinephrine, for example) oranesthetics. It should be noted mat such biologically-active substancesmay also be delivered at any stage of the biopsy procedure, eitherdirectly through the open beaks, through the living hinges of the closedbeaks or via a reverse flow from the flush system built into the device.After or instead of such an optional injection stage, the distal beak orbeaks or work element 13 may then be opened and advanced along thescoopula-shaped distal portion of the outer sheath and may be caused torotate to facilitate penetration through the tissue and coring. Therotation and advancement of the distal beak or beaks 13 may be caused tostop just at or near the forward edge of the scoopula leaving, accordingto one embodiment, no or substantially no dead space at the distal-mosttip of the present biopsy device that would otherwise be unavailable forsample acquisition. The coring may then continue as normally encounteredin stereotactic procedures, i.e., around the clock face but alsolaterally in any direction with the present device, and in either anautomatic or semiautomatic mode. During one or more of the corings, arecord stage may be activated to halt the coring stage just after thespecimen has been parted-off in order to enable the practitioner torecord image(s) of the shaft or scoopula of the biopsy device in placein the lesion, and to record and document that core samples in thetransfer magazine 27 (particularly those of different chosen lengthsobtained serially during the procedure) were acquired precisely andsequentially from the previously-imaged lesions. Following theacquisition of a sufficient number of core samples and following theherein aforementioned documentation stage, the core sample acquisitionsite may be firmly correlated with the image abnormality location.

Another embodiment is another method of carrying out a biopsy. Such amethod may comprise imaging the tissue of the organ (the breast, in thisexample) of interest and identifying the target lesion(s) or tissue tobe removed or biopsied. The skin may then be cleaned using steriletechniques, the patient may be draped and anesthetics may be delivered.In the case wherein the present biopsy device is configured to enableindependent forward firing of the outer sheath or scoopula, the devicemay be introduced through the skin nick in the “pre-fire” loadedposition and moved forward with or without rotation to the nearest edgeof as imaged lesion. At that point, the operator would release thescoopula to the forward under the force of a spring or compressed gas,such as a CO₂ cartridge for example, or manually, or fey any othermechanical means, including pressurized fluids for example, or byelectromechanical means. Once fired, the scoopula would enter the lesioncenter with little if any residual shift in the lesion position, even ifthe lesion were to be of a firm nature (as in a benign fibroadenoma, ora malignant carcinoma for example) and even if situated within veryelastic fatty/fibrous tissue such as exists in the majority of otherwisenormal breast organs. Once across the target lesion and approximatelycentered, the scoopula may be re-imaged for verification purposes and toprecisely correlate the biopsy device position with respect to imagedabnormality. Additionally, the device may then be easily manipulated forfine-tuning purposes if desired. Also, were the scoopula to be fired toa position close to a nearby vulnerable structure (whether tissue orradiology backing plate or other), the operator may then be able toadvance carefully the last few millimeters to the most optimal location.After these maneuvers and verifications have been completed, the targetis now fixed by virtue of the pinning stabilization effect of thescoopula component. This enables the operator to then proceed with anumber of options. First, the operator may elect to deliver substancesin a more pinpoint location using the scoopula as a reference as well asa delivery pathway. For example, a radiation source could be introducedthrough the central lumen, antibiotics and/or local anestheticmedications as well as coagulants and/or vasoconstrictors may beintroduced. Likewise tracer elements to trace the pathway to sentinelnode drainage may be introduced at this stage of the procedure such thatsufficient time passes while the rest of the biopsy procedure iscompleted to enable detection in the sentinel node toward the end of orafter the biopsy portion of the procedure has been completed. Anotheroption is to simply proceed with multi-sample biopsy while taking cores“about the clock face” as previously described. Following sampling tocompletion, other options may follow such as halting the coring beaks inopen and proximal position while leaving the scoopula distally placed,such that post-procedure elements may then be introduced via thedistally placed (across the lesion that had been completely sampled orremoved) scoopula, precisely in the place of the biopsy sampling. Theseelements could include implants such as cosmetic filer/deliverysubstances as well as oilier post-procedure devices that may beintroduced via the central lumen/scoopula pathway, such as an electronbeam reflector, a fiber-optic scope, an ultrasound transducer, acryotherapy element such as an “ice-ball-on-a-stick” probe (as describedin more detail in the following paragraph), a laser or radiofrequencytissue ablating device or even an optical signal acquisition andprocessing device to capture micrometer-resolution, three-dimensionalimages. Upon completion of any of these options, the scoopula may bedetached and left in place for other purposes or may optionally beremoved together with the parent device and then the procedureterminated in the usual way with control of any bleeding, closure of theskin nick and the usual post-procedure dressing(s).

An embodiment of a biopsy device additionally includes an independentlymovable or fixed guiding, element such as a stiff or floppy wire thatslay lead the way through a natural surface plane or lumen of a hollowbody such as a duct, lymphatic space, blood vessel or other naturalspace or potential space. Such a guiding element could be pre-placed andthen elements of a biopsy device advanced over the guiding element.Alternatively, a guiding element may be tired forward in the same manneras the scoopula described above, or it may simply be fixed near or at aforward (distal) position of elements of the biopsy device. Furtherstill, a guiding element could be coaxial with, in tandem with oradjacent to the long axis of elements of the biopsy device. The guidingelement could additionally, be a completely separate entity that may bepre-placed by an operator skilled in imaging and targeting and fixed inplace near or within the target tissue. After placement and fixation anoperator may then proceed by advancing the biopsy instrument over thepreviously precisely placed and anchored guiding element.

Embodiments of the biopsy device, along with related subcomponents andfeatures, may also be configured for imaging of the surrounding tissueduring pre-operative, infra-operative, and/or post-operative phases ofthe device clinical use. One embodiment for imaging integration may beimplemented by insertion of a transducer or associated opticalcomponents for ultrasound imaging, direct visual imaging, or OpticalCoherence Tomography (OCT), through the lumen of the biopsy device whichmay be carried out at any one or multiples of the afore-mentionedphases. The transducer may be comprised of a single element, a phasedarray, or a stacked array and may be fixed or move in rotation ortranslation relative to the scoopula and may move with a beak(s).Embodiments of the biopsy device might incorporate imaging transducer'sin parts of distal biopsy device subassemblies such as the distalportion of the outer sheath or scoopula or as a part of the beak.Embodiments of the biopsy device could also use a lumen for free-spacecoupling of laser or broad spectrum light into and/or out of the tissueand may use the living hinge or a reflective component attached theretoto direct or steer the electromagnetic radiation. The internal surfacesof the tubes or scoopula may also act as reflectors or directors for thelight beam. Embodiments of the biopsy device may also be configured toallow for ablation of tissue during pre-operative, intra-operative,and/or post-operative phases. Ablation may be accomplished through oneor more combinations of hyperthermic ablation (such as radiofrequency,microwave, laser, and ultrasound) and/or cryoablation techniques. Theablation sub-assembly may attain access through the central lumen of thebiopsy device, may be an integral part of the biopsy device, or mayconnect to or be inserted through a portion of the biopsy device that isleft in the body providing; appropriate access to the tissue site. Oneembodiment may use radio frequency ablation techniques where parts ofthe scoopula or beaks are energized. The relative rotation and/orplacement of the distal components of the biopsy device may serve toselectively direct and/or focus the energy. The sub-assemblies toaccomplish this may be an integral part of the biopsy device or may beinserted through, the lumen of the biopsy device. These sub-assembliesmay be configured to interact with elements of the distal scoopula toraise them into position needed for then function and these interactionsmay also enable them to perform a part of the biopsy procedure itself,such as forming a surface against which part-off may be accomplished.They may also accomplish coring and/or part off by themselves (throughflexing, rotation or other actions as described for beak elements, or bybeing energized) or in combination with surfaces of the scoopula or withother elements introduced along the scoopula including physical elementsand/or beams or other forms of energy such as electromagnetic sources,heat sources and others, according to embodiments. Another embodimentmay use microwave radiation ablation and may incorporate antennaeelements into the beak, outer tube or scoopula or may incorporateantennae elements in a sub-assembly that could be inserted through thecentral lumen or in close proximity to the axial length of the tubularcoring and transport assembly 11 (just underneath or alongside, forexample) of the biopsy device when desired. The location of the antennaemay be varied along the axial length of the open scoopula and may alsobe rotated relative to the scoopula resulting in selectively directingthe microwave energy. Furthermore, electro-magnetic reflectors could bebuilt into the scoopula or other members and stacked or phased arrays ofantennae may be employed to further direct or dynamically time theradiation pattern. Another embodiment may also use electron-beamablation and may incorporate a beam guide tube that may be insertedthrough a lumen in the biopsy device to deliver the electron beam toselective locations in the tissue surrounding the device. Anotherembodiment may use laser ablation and may deliver and direct the laserbeam through an optical fiber or through a free-space coupled beam. Thebeam or fiber may be directed by a reflective surface on or attached tothe internal angle of the living hinge and/or a reflective surface ofthe scoopula. This may allow the beam to be directed in a patternoptimal for the desired ablation. The laser ablation sub-assembly mayuse the central lumen to deliver the light to the distal portion of thebiopsy device or may attach to an integral optical delivery system.Another embodiment of the biopsy device may include a probe thatprovides cryosurgical ablation of tissue surrounding a cold probe thatmay be inserted through or be integral to the biopsy device. The coldprobe may repeatedly warm and rapidly cool the surrounding tissueresulting in ablation. The probe may be positioned relative to thescoopula such that the rotatable scoopula provides a heat sinkselectively shielding tissue from ablation.

Upon completion of the biopsy procedure and, if desired, prior toremoval of the device, a specimen ultrasound or a radiograph may becarried out upon the specimens collected within the transfer magazine27, which magazine may be specifically configured for echo- andradio-lucency as well as compatibility with MRI and/or other imagingtechnologies. The removable transfer magazine 27 may then be placed intoa receptacle that may be preloaded with preservative and sealed. Ifdesired, a replacement transfer magazine 27 may then be loaded into thebiopsy device to continue the biopsy procedure. Alternatively, with thebiopsy device 10 in place, an adapter configured for the delivery ofmaterials to the biopsy site may be substituted for the transfermagazine 27 at any time. Alternatively, with the biopsy device 10 inplace, the tissue transfer magazine 27 may be removed and replaced withas injection cartridge that may be pre-loaded with post-biopsy elementssuch as medications, cosmetic implants, brachytherapy elements such as aradio-active seeds, and/or a porous element loaded with a biologicallyactive substance and/or other materials. Alternatively still, the biopsydevice 10 may be withdrawn from the removable outer sheath, which outersheath may then be used for delivery of post-procedure materials to thetarget site while other components of the biopsy device may be packagedappropriately and delivered to an appropriate laboratory forpathology/cytology analysis. The outer sheath of the biopsy device maythen be completely removed from the site and the wound dressed using thecustomary standard of care procedures. If so attached to biopsy device10 via an aspiration/material delivery port 639, a liquid aspiratestorage vessel may be removed from biopsy device 10 at any time andcapped securely for transport to an appropriate laboratory for cellularand subcellular analysis. An illustrative placement of anaspiration/material, delivery port 639 on biopsy device 10 is shown inFIG. 1 herein.

FIG. 1 also shows illustrative placement of various external controls,including a depth stop adjustment mechanism 630, a forward firingtrigger and lever 631, a drive train carrier bolt 632, a manual part-offlever 633, and a cam clutch button 634, as well as other features suchas a power switch/indicator 635, a DC power plug 637, a flush port 638and an aspiration/material delivery port 639, which will be discussed inmore detail in hut her figures. The placement of these external controlsis illustrative in nature and embodiments may contain some or all ofthese controls in the locations shown in FIG. 1 or other locations.

It is to be understood that the above descriptions are but exemplarymethodologies and that one or more of the steps, described above may beomitted, while other steps may be added thereto to any of theseembodiments, depending on the target site within the body, which is notlimited to the breast. Other operator method embodiments and device 10embodiments are supported as well. The order of some of the steps mayadditionally be changed, according to the desired procedure.

FIG. 2 shows a distal end of a coring and transport assembly 11 of FIG.1, with a configuration of a manually rotatable outer sheath 512, havinga distal tip in the form of an edge-sharpened trough or scoopula. Asshown, the coring and transport assembly 11 may comprise a rotating andlongitudinally movable (e.g., selectably movable in the distal andproximal directions) articulable beak (or work element) 13, which may,in one embodiment, be actuated by an internal helix 472. Although asingle beak is shown and described in this figure and some of thefollowing figures, it is to be understood that more than one beak may beused in embodiments, and for that reason, whether only one beak, doublebeaks or multiple beaks are described herein, all such embodiments areconsidered to be within the scope of this disclosure. If more than onebeak is present, then individual shapes may be asymmetric to each otheror have differing features. As described above, upon entry of the coringand transport assembly 11 to the target site within the body aprocedural option may be chosen where only the scoopula-shaped distalportion of the outer sheath may be exposed, and the work element may beheld in place at the proximal opening of the scoopula. As the device isadvanced, the sharpened trough-like scoopula may be made to cut its wayforward in the distal direction, with little disturbance to the targetlesion. Indeed, as the scoopula-shaped distal portion of the outersheath presents a minimized cross section (as compared, for example, tothe cross-sectional profile presented by a tube), dissection of thetissue path to the lesion occurs with reduced distally-directed forceand little disturbance to the surrounding tissue and to the targetlesion. This is a significant feature of the device 10, according toembodiments, because with a minimized cross-section, such a scoopula maybe made to cross the lesion (or tissue immediately adjacent thereto)with minimal disturbance to or displacement of the lesion and may alsobe moved laterally for precise positioning, as previously discussedherein. As coring has not yet occurred, the scoopula-shaped distalportion of the outer sheath, enables the device 10 to be advanced to orpast the target lesion with a reduced chance of transporting potentiallymalignant cells or material through the lesion to otherwise healthytissue. A further advantage of optionally advancing only the troughshaped scoopula is that it minimizes both physical and visual distortionof the image, enabling a guidance modality to identify structures nearlyas easily as before anything was introduced across the lesion, enablingpositive correlation between the imaged tissue and later pathologyfindings. It is to be understood that, according to embodiments, thephrase “scoopula-shaped distal portion of the outer sheath” is intendedto encompass a distal portion of the outer sheath that is shaped so asto present an open portion or a less-than foil cross-section, ascompared to more proximally-disposed portion(s) of the outer sheath 512.

The sides or edges of the distal scoopula may be sharpened, may beparallel to the long axis, or may be of varying profile with respect tothe long axis. For example, the sidewalk of the scoopula may begradually rising from its distal to proximal portions, enablingpre-severing of the tissue prior to engagement of the beak or beaks workelement. Some or all of the edges of the scoopula, including the “roof”or proximal arch of the scoopula, may be sharpened, serrated orotherwise configured in order to optimize coring and/or stabilizingactions as well as to permit a variety of pathways for aiding coresample transport, such as fluid flush and vacuum. In one embodiment, abeak or beaks work element by itself may sever tissue without the needto contact any surface of the scoopula, simply by nature of the shearingaction and by virtue of exceeding foe elastic limit of the tissue astissue is forced over the edges of the scoopula. With a distal scoopulaacting as a stabilizer and being anchored through the lesion, the workelement (single beak, multiple beaks etc.) may then be made to moveaxially in a distal direction and, according to one embodiment underrotation. This effectively combines a forward cutting mechanism, withreference to a single rotating beak (or multiple beaks) acting againstthe sides or edges of the scoopula, as such a beak or beaks movesforward with a scissors-like action against the side of the scoopula,and a side cutting mechanism from the point of perspective of thescoopula, as the sharpened sides of the beak or beaks bear against thesides or edges of the scoopula, according to embodiments, in oneembodiment, a beak or beaks work element by itself may sever tissuewithout the need to contact any surface of the scoopula, simply bynature of the shearing action and by virtue of exceeding the elasticlimit of the tissue as tissue is forced over the edges of the scoopula.FIG. 2 shows the coring beak disposed distally almost all the wayforward to its part-off point and rotated slightly as it would be seenas a snapshot of its continuous forward travel while rotating, coring,and then eventually parting off as it reaches the end of the scoopula.The coring beak may then be configured to part-off the cored sample byclosing down against the inside diameter of the scoopula. Upon finishingits coring cycle, the work element may be configured to withdraw underrotation or not back to its initial position (according to oneembodiment, adjacent to the proximal opening of the scoopula), therebytransferring the parted-off sample proximally to an internal transportmechanism and continuing to a transfer magazine 27 (not shown). In theembodiment illustrated in FIG. 2, such internal transport may be earnedout by a rotating helix or helices 472 disposed in the central lumen ofthe device. It should be noted that the centrally-disposed helix 472shown in FIG. 2 is but one possible mechanism to rotate the beakelement(s) 13 and to transport parted-off cored samples in the proximaldirection, and embodiments are not to be limited thereby.

Significantly, if the operator allows full forward travel of the workelement(s) 13, there will be no or substantially no distal tip deadspace, i.e. the device will sample (e.g., core) all the way to orsubstantially to the distal-most tip of the scoopula within or past thelesion, as originally placed. This lack of dead space allows optimalplacement of the excisional device 10 in relation to physical structuressuch as the chest wall, radiology backing imaging plates or otherstructures associated with either the body or the supporting device,such as a stereotactic table. If the device is used with a stereotactictable, either the device itself, in one embodiment, or the outer sheath,in one embodiment, may then be rotated “around the clock” such that theopen portion of the scoopula faces the next desired clock face positionand coring may begin again, repeating as often as desired, selectivelyfully or partially. It should also be noted that, because the distal endand edges of the scoopula may be very sharp, according to oneembodiment, lateral displacement of the distal end of the device 10 maybe accomplished, either with or without rotation of the outer sheath,thus giving the operator greater flexibility to pursue the edges of alesion that may not be spherical in shape. As noted above, medicationsand other materials may be delivered to the target site. A vacuum sourceconnected to an aspiration/material delivery port that may be configuredfor aspiration may be used to collect the tissue samples, cells andfluids either originating from the site or injected to the site, forinstance, as well as to aid in transporting the severed tissue specimensproximally to, in one embodiment, transfer magazine 27. Such vacuumsource may be connected to a port located on, in one embodiment thehandle, for example 639, or in another embodiment located on thescoopula.

FIG. 3 illustrates distal details of the work element and scoopula ofFIG. 2, showing an embodiment having a relatively shortened scoopulaportion of the outer sheath 512. In FIG. 3, the outer sheath 512 is cutaway to show the internal helix 472 (also shown as element 582 in laterfigures), according to one embodiment. Hie embodiment of FIG. 3 may findparticular utility in tissue coring applications outside the breast,such as bone. The shortened scoopula portion of the outer sheath 512 mayalso be useful next to sensitive structures in general and incardiovascular applications in particular. It should be noted that thescoopula and its corresponding work element may be of any lengthnecessary to match a particular tissue, target lesion, and/or site,according to embodiments. In this figure, the beak of the work element13 is shown opened over center, and as it rotates it is thus forced toclose down slightly against the edges of the scoopula and parallel withthe long axis of the helix, which supplies either some or all of therotating force, according to one embodiment. In this view, it can easilybe envisioned that much or all of the rotating force may also besupplied to the beak by an extended collar to which the beak may beattached, in one embodiment, by a living hinge 458, as will be describedlater in more detail in oilier figures. According to one embodiment aninternal helix 472 may be configured to provide the axial force that isnecessary to open and close the beak(s) against the scoopula for tissuepart-off and retrieval and transport.

According to one embodiment a helical element 472 and a firstarticulable beak element 13 (or first and second articulable beaks in adouble beak configuration, according to embodiments described hereinbelow) may be configured to rotate at a rotation rate of between, forexample, 0 to about 10,000 rpm. For example, a rotation rate of between,about 3,000 and 7,000 rpm may be selected for parts of a procedure.According to one embodiment, a dither or slight jittering of thearticulable beak elements may be implemented in place of or imposed ontop of the rotation. One implementation calls for a rotation rate ofabout 5,000 rpm (plus or minus about 20%) during at least one phase ofthe tissue coring, and excision process. According to one embodiment, ahelical element 472 may define a single-coil configuration. According toembodiments, the helical element or elements may be provided withstructure configured to increase its column, strength and torque and todecrease the torsional deformation thereof. For example, such a firsthelical element 472 may comprise a two or three (or more) coilstructures. Collectively, these coils may decrease the tendency of ahelical element 472 to compress, may increase the torque that it mayapply against the tissue through the first or first and secondarticulable beaks and may increase its resistance to deformation as itis rotated. Such a configuration may also spread the torque load tomultiple points of attachment with the first and/or first and second ormultiple articulable beaks.

FIG. 4 illustrates the same components of FIG. 3, but in a differentsnapshot of time, corresponding to a later period where the beak element13 is shown rotating to core the tissue and nearing its final part-offpoint by action of a single beak closing, in this embodiment against theend of the scoopula, which in this embodiment acts as a second, non- ordifferentially rotating beak in relation to the single beak 13 shown inthis view. Differential rotation as used herein implies and encompassesdifferent rotation speeds in both the same and opposite directionsbetween individual elements.

FIG. 5 illustrates the same components of FIGS. 2-4, but in this case,the operator has chosen to manually part-off the sample before the beakelement 13 has reached the distal end of the scoopula portion of anouter sheath 512, an operation made possible by the drive mechanism ofone embodiment of this device, as is described below in later figures.The beak element 13 in such an embodiment, may also comprise a livingbinge 458. According to one embodiment, a living hinge 458 may comprisean H-shaped series of stress-relieving kerfs and relieving features atthe ends of the kerf cuts, allowing the beak element to close againstany portion of the scoopula. These stress-relieving kerfs may reduce thestress induced in the living hinge 458 to a non-inclusive range, forexample of 10 to 360 ksi (kips per square inch). These elements of aliving hinge 458 may also, according to embodiments, serve as conduitsfor medications (anesthetics and epinephrine, for example) and otherliquids, such as saline flushes. Such conduits enable such fluids toflow through the central lumen of the device 10 for delivery to thedistal end thereof even, if the beak(s) may be closed during such, anintra-operative procedure.

FIG. 6 is a side view of the components of FIGS. 2-5. In thisillustration, a more typical part-off point is shown with the forwardedges of a trough-shaped scoopula beak and the active beak perfectly ornear-perfectly opposed, eliminating all or substantially all dead spaceat the distal end of the device. One beak attachment tab is showninteracting with the distal end of a helical element 472.

FIG. 7 shows a view of a variant of the distal end of the device,according to one embodiment, that comprises an extended collar on asingle beak assembly 13 revealed where the outer tubular element 512 iscut away to reveal the attachment point of the extended collar with ahelical inner tubular element 472, as shown in FIG. 6. This variant,provides greater stability in the trough-shaped scoopula sections oftravel of the inner coring, cutting, transport and part-off activeportion of the device and enables high-speed spinning of the active beakelement during coring, while protecting the tissue sample from beingexposed to high speed helical motion until it has the opportunity tomove along the helical portion axially after being fully parted off fromthe host tissue. Details of active beak attachment are not shown in thisillustration.

FIG. 8 shows details of a single distal active beak 13 attachment toelements of a split collar using torsion bar 13A and bands 13B toaccommodate the transfer of forces needed to open, close, and stabilizethe active beak element 13, according to one embodiment. By relativeaxial movement of the lower half 13D to the upper half 13C of the splitcollar extension of the beak 13, the bands 13B move proximally causingthe beak 13 to close, as shown later in FIG. 11. In such an embodiment,such attachments may simplify the attachment and bending requirements ofthe active beak(s) such that they may not interfere with sampleacquisition and transfer to transport components of the coring andtransport assembly 11 of the device, according to this embodiment. Suchsplit collar extension may be configured to have a straight longitudinalsplit in one embodiment, or a curved split with respect to die long axisof the device, in other embodiments. Such a curved split with respect tothe long axis of the device will impart twisting of the beak or beaks asthey close down, which may aid in part off, particularly if the twist,is in the opposite direction of the beak assembly rotation. Not shown inthis view is the outer sheath 512.

FIG. 9 shows the same configuration as in FIG. 8 above, but in asnapshot position showing a scissors-like spring-jaws action of a beakagainst the scoopula portion of the outer sheath 512, which is shown inthis view. Such spring-jaws action is enabled by opening the singlebeak, in this illustration, more than it would be if the back of thebeak 13 remained parallel with the extended collar to which it isattached, or effectively over center, in this view, the torsion bar 13Aattached to the proximal end of the beak and the distal end of the upperhalf 13C of the split collar to which the beak is attached is shownbeing flexed in a twisting motion to provide a force against which thebeak opens. Such a configuration of being open over center causes thebeak edges to come in very close proximity with the edges of thescoopula of the outer sheath 512 with every revolution. In this case,the spring action is provided proximally by a helical element andtransmitted forward via the lower collar half 13D of the split collar,which is attached to the bands 13B (similar in action to beak openingand closing tendon elements 468 disclosed in further figures below). Theactive beak element 13 (active in that it moves from an over center openposition to a parallel open position) is forced to conform to the troughdimensions of the scoopula each time it comes around in its rotation.Resisting this conformation is the axial force of a helical elementacting through a lower collar half 13D and a torsion bar 13A. Thisresults in a powerful shearing action of the active beak against theedges of the scoopula (in this illustration—an inactive or fixedstructure). It may also enable a slightly larger sample to be acquiredand forced into the collar section. Additionally, the conformation of anactive beak relative to a trough section with each rotational cycle ofthe active beak creates a slight repeated back and forth motion of alower collar half 13D as compared with an upper collar half 13C and thusan axial oscillation action between lower and upper halves of anextended collar section, which may tend to move the severed tissuespecimen axially in a proximal direction. If inner elements such asscales etched or ground into the inner diameter of a split collar areadded to such an embodiment to take advantage of the axial tissuespecimen movement gamed by this repeated back and forth action, aratcheting mechanism to aid delivery of tissue to a transport section ofthe device may be created. Other inner wall treatments such as rifling,among such treatments, may also be added to aid in the transport of thecored and parted-off tissue samples in the proximal direction.

FIG. 10, further to the points above, shows an active beak nearlycompleting its forced compliance with the inner diameter of atrough-shaped scoopula of an outer sheath element during a snapshot intime of its rotation/forward movement. It should be noted that sharpedges of an outer sheath scoopula 512 as shown may be beveled eitherexternally or internally, according to embodiments. FIG. 11 shows thesame components of FIGS. 9 and 10, but now showing an active single beakin close apposition with the forward edges of the scoopula section of anouter sheath 512. This illustration shows another embodiment of theshape of the edges of a trough or scoopula section, which, particularlyif enabled to be oscillating, may aid in coring and thus facilitate thedistal advancement of an entire distal portion of the biopsy device atthe initial stages of the procedure. The edges of the scoopula may alsobe asymmetrical at any point relative to any other point, according toembodiments.

FIG. 12 shows the same components as are shown in FIGS. 9, 10 and 11,but from a top view perspective. This view shows a torsion bar ISA inclose proximity to the proximal portion or base of an active beak 13with respect to the upper half 13C of an extended collar portion of anactive beak assembly, according to one embodiment. Various methods ofattachment of a torsion bar to the base of a beak 13 may be envisioned,and are not specifically described herein.

FIG. 13 shows the embodiment of FIG. 2, viewed facing the distal end.FIG. 13 shows an exaggerated beak opening for illustrative purposes.Couplings are shown mechanically linking a helical element 472 and theproximal portion of a moveable beak 13. Other coupling arrangements featcouple a tubular coring and transport assembly (or, simply, the proximalend of the device) are possible and fall within the scope of thisdisclosure. Again, sharpened bevels of an outer sheath 512 and a beak 13may be internal or external or opposite to one another.

FIG. 14A shows the configuration of a tubular transport and coringassembly 11 of FIG. 13, showing forced compliance cycling of an activebeak element 13 with the inside diameter of the scoopula portion of anouter sheath 512, according to one embodiment. In this case, the beakwas opened over center, as in FIG. 13, and as rotation occurs, the beakmust move back to a fully opened, but not over center, position,eventually as a straight extension, of a helical element 472, until itmoves past the opposite edge of outer sheath 512's scoopula and then canagain open slightly over center.

FIG. 14B shows the features of components of FIG. 14A, according to oneembodiment, but now showing nearly completed forced compliance of anactive beak element 13 alignment with the inside diameter of thescoopula portion of an outer sheath 512.

FIG. 15A is a perspective view of a split-tube single beak assembly 13in retracted position against an outer sheath 512 that terminates in ascoopula. Shown in this view is a living hinge 458, which attaches adistal beak to an upper half 13C (FIG. 15B) of a split tube and whichallows the beak 13 to close down against the inside diameter of ascoopula 512 of an outer sheath, as will be shown and described in laterfigures. Element 458 may be considered to be similar in function to thetorsion bar 13A described relative to the previous FIG. 8 above. Theaction of a living hinge 458 provides positive attachment to both thedistal tip of a beak assembly 13 as well as the upper half 13C of asplit tube. The split tube may be similar in nature to a split collarupper half 13C and lower half 13D previously described, albeit longerthan a split collar. The split tube may be of such a length as to becoupled directly to its own rotational and axial drive mechanism withina handle 12 of the biopsy device, to allow beak actuation and rotation.In the position shown in this figure, the beak 13 may not be rotating atail, in order to facilitate the forward penetration of the excisionaldevice to a target tissue site within the body, as previously describedabove, according to embodiments.

FIG. 15B is a perspective view of a split-tube single beak assemblyextending parity out of an outer sheath, with a beak open over-centerand selectively under rotation about longitudinal axis 14 or not.According to one embodiment, the beak(s) 13 may also be configured tomove substantially parallel to this longitudinal axis 14, as the beak(s)13 move from a retracted position to a parting-off position in which thedistal tip of beak 13 extends substantially to the distal tip of outersheath 512, to thereby achieve substantially zero dead space. Theover-center action of the beak is due to an attachment of two beakopening and closing tendons 468 formed with a beak (one on either side)and the lower half of a split tube, shown as element 13D in this view.The upper half of a split tube 13C may be attached to the proximal endof a living hinge 458. Relative axial movement between an upper half 13Cand lower half 13D of the split tube actuates a beak 13 to open andclose. Such axial movement may be limited, in embodiments by a T-shapedor otherwise shaped tab that may be formed as part, of a lower tube half13D sliding within a travel minting slot 467 in an upper half 13C of asplit tube, according to one embodiment or opposite in otherembodiments, as well as being of any shape. Several of these tabs andslots may be arranged along the length of a split tube, and the split,tube, beak, living hinge and tendons may be formed of a single tubethat, may be, for example, laser cut. Additionally, the slot(s) 467 maybe filled with a flexible substance, such as silicone, that may also beprovided with a small hole that will open and close as a T-shaped tabmoves axially in the slot. According to embodiments, this may allowflush fluids drawn between an outer sheath 512 and a split tube toselectively pass into the central lumen of a split tube to aid in tissuespecimen transport. It should also be noted that according to oneembodiment a single axially split tube may have more than one beak,configured with a movable beak attached to the upper half 13C of a splittube with a living hinge and tendons, as described above, and a fixedbeak as a distal extension of the lower half 13D of the split tube, i.e.distal to the attachment points of the proximal ends of the tendons asan extension of the lower half 13D. Such a fixed beak in the lower half13D may be thought of as a short scoopula, mimicking that, of the outersheath 512, but shorter, and in fact reaching distally only to the pointwhere the movable beak would close down against it. In such anembodiment, the beak assembly would be capable of both coring andparting off a tissue specimen beyond the end of the outer sheath 512scoopula, if desired. This embodiment is not illustrated, but may beeasily envisioned by imagining that the split tube beak assembly of FIG.15B had an extended fixed beak as part of the lower half 13D of thesplit tube. Under rotation, either a split tube single beak embodimentor a split tube double beak embodiment, will part off a tissue specimenif the movable beak moves to at least the longitudinal axis 14 of FIG.15B.

FIG. 15B also shows that at least the outer sheath 512 may be rotated,as suggested at 16. In so doing, the sharpened edge of the openscoopula-shaped distal portion of the outer sheath 512 cuts through anarc of tissue. According to one embodiment and as shown in FIG. 15B, thearc of tissue along 16 may be oriented substantially normal to the longaxis 17 of the tissue specimen 18. That is, according to one embodiment,the open scoopula-shaped distal portion of the outer sheath 512 may berotated about its longitudinal axis (e.g., 14 in FIG. 15B), which isnormal to the long axis 17 of the tissue specimen 18. As also shown inFIG. 15B, the specimen 18 may (but need not) be shaped like a shortsegment of a tube, with tapered proximal and distal ends. Afterobtaining a first tissue specimen, further tissue specimens may be cutfrom the tissue then facing the open scoopula-shaped distal portion ofthe just-rotated outer sheath 512, which facing tissue may be radiallyseparated from the tissue from which the previous, pre-rotation specimenwas cut. After rotating the open scoopula-shaped distal portion of theouter sheath 512, a radially-directed force may be imparted on thebiopsy device, to cause tissue to prolapse into the scoopula-shapeddistal portion or to increase the amount of tissue that prolapsestherein. This may increase the quality of the tissue specimen, dependingupon, for example, the type and architecture of the tissue being cut.

FIG. 15C is a perspective view of a split-tube single beak assembly infully extended position at the end of the scoopula of an outer sheath,which position is suitable for part-off of a tissue specimen and forother purposes, including penetration to a target tissue site orrepositioning to a second target site, according to embodiments. Theelements of a living hinge 458, the distal tip of a beak assembly 13, anouter sheath 512, the upper half 13C of a split tube of such amonolithic beak assembly, and a slot 467 with its distance limiting tabmay be seen in this view.

Turning now to further embodiments and in greater detail, the discussionthat follows will focus on general features of an entire device 10 forpurposes of illustrating its enabling mechanisms, which may comprise adistal end consisting of an outer sheath, an inner or distal sheath, aproximal sheath, work element or elements and such features as first,second and third helical elements, in any combination, as well as otherelements such as suggested by FIG. 1 or previous figures and as detailedfurther below. The description below begins at the distal end andcontinues to the proximal end of the device 10, and embodiments mayinclude any or all of these elements, according to individualembodiments.

FIG. 16A shows details of a work element and FIG. 16B shows a workelement in relation to an outer sheath 512 ending in a scoopula shape ofan excisional device according to one embodiment. As shown, a first or,according to some embodiments, a first and second (or more) articulablebeaks 13 may comprise one or more slots 461 defined therein to form aliving hinge or hinges 458. For example slots 461 may have lengthsranging non-inclusively from 0.050 inches to 0.500 inches. Theseparation between adjacent slots 461 may also be in the range of 0.005inches to 0.050 inches or up to ⅔ of me distal tube internal diameter.The thickness of living hinge 458 may be different in thickness than,that of the surrounding material and may be in the range of 0.001 inchesto 0.015 inches. The range of motion of the living hinges 458 may befrom 5 degrees to 75 degrees with respect to the longitudinal axis ofthe outer sheath 512. Living hinges 458 could be fabricated fromcurrently existing alloys such as a stainless steel, for example, 304,316 or 440, in different tempers or work hardened states, nickeltitanium alloys, managing steel, composite materials such as made fromfibers, for example, carbon fiber, and/or future high ductility alloys.Additionally, wedge-shaped (for example) cutouts 466, which may be leftjoined at the base of the wedge adjacent to slots 461, may be providedto define the articulable beaks of a work element 13, to improve thearticulation thereof, and to provide for a great range of motion.According to embodiments, each of a first and second articulable beaktips 452, 454 may define or may be coupled to a first tendon 468 coupledto one side of the first articulable beak and a second tendon 470coupled to the other side of the first articulable beak. Alternatively,a single tendon may be defined or multiple tendons may be defined.Additionally, these tendons may be defined at different relative anglesto each other to impose an unequal or asymmetrical force to the sides ofthe distal end of an articulable beak tip 452 or 454, in embodiments.These first and second tendons 468, 470 may be configured to selectivelyapply a proximally-directed force and a distally-directed force to thedistal portion of an articulable beak to cause the first and secondarticulable beak tips 452, 454 to assume their closed and progressivelyopen configurations, respectively, or in the case of a single beakconfiguration, to open or close at some (which may be user-selectable)point along a scoopula of an outer sheath (as shown in FIG. 16B).Indeed, pulling on the first and second tendons 468, 470 by a proximalforce acting on an actuating element 469 tends to close the first andsecond articulable beak tips 452, 454 (i.e., draw the respective distaltips closer to the longitudinal axis and closer to one another) andpushing on the first and second tendons 468, 470 tends to open the firstand second articulable beak tips 452, 454 (i.e., draw the respectivedistal tips away from the longitudinal axis and away from one another).Tendons 468, 470 may be fabricated using the same engineeringprinciples, concepts and material considerations as for the living hinge458. Geometry of the tendons may be designed to ensure the foil closurestress levels be kept in the 10 ksi to 360 ksi range. The width andheight of the tendon element may have non-square and/or non-constantcross sections, as elliptical for example, in the range of 0.0005 inchto 0.015 inch on a side. The lengths of the tendon flexures could be inthe range of 0.025 inches to 0.500 inches.

FIG. 16B shows a work element (shows as cutting elements 13 in theembodiment of FIG. 1) comprising, in one embodiment, twin articulablebeaks 516 and 518 (numbered differently in this illustration to indicatemat the entire beak or beaks may be comprised of many features alreadyoutlined in FIG. 16A) and outer sheath 512 of an excisional deviceaccording to one embodiment. As shown therein, an excisional device,according to one embodiment, may comprise an outer sheath 512 defining alongitudinal axis whose distal end, as shown, may comprise a scoopula(seen, from the top down and shortened in this view, not necessarily toscale), trough or other leading edge shape. According to one embodimentthe distal edge or edges of such scoopula, trough or other distalfeature may be sharpened at least, partially around its circumferenceand side edges as desired. A work element may be configured to at leastpartially fit within an outer sheath 512 and may be configured to bewithdrawn in the proximal direction into an outer sheath 512 and extendout in the distal direction at or near the end of the distal free end ofa scoopula while lying within its curvature. The work element, accordingto one embodiment, may comprise a single beak (518, although 516 couldbe chosen as well since the work element rotates and such a single beakmay act against the scoopula portion of the outer sheath 512 as shown inFIGS. 2-15 above). A beak 518 or 516 may be configured, including by itsshape, according to one embodiment to close against, the inside diameterof a scoopula at any point along its length, as shown in previousfigures, as well as the distal-most edge of the scoopula, which shapemay be similar to beak(s). The beak(s) may be configured to rotatewithin an outer sheath 512 about the longitudinal axis thereof. As shownin FIG. 16B and other figures, a first and/or first and secondarticulable beaks 516, 518 may define respective first and second curveddistal surfaces configured to cut tissue. The work element may befurther configured to be advanced distally such that at least a firstand second curved distal surfaces of a beak or first and secondarticulable beaks 516, 518 are at least partially disposed outside of adistal outer sheath (not shown in FIG. 16B). As particularly shown inFIG. 13, a portion of both of the first and second curved surfaces of asingle beak or of the first and second articulable beaks 516, 518 may beconfigured to rotate at least partially outside of an outer sheath 512,with the remaining portions thereof configured to rotate within an outersheath 512.

Indeed, in this embodiment, a substantial portion of a first and secondarticulable beaks 516, 518 may be configured to rotate within an outersheath 512. This configuration radially supports a first and second,articulable beaks 516, 518, and prevents them from over-extending orotherwise undesirably deforming when cutting through tough tissue.According to one embodiment, a shearing or scissors action may beimparted, as the distal tips of a first and second articulable beaks516, 518 rotate inside the extremity of an outer sheath 512 and act withtheir sharpened edges against the side edges of an outer differentiallyor non-rotating sheath 512 as previously described. According to oneembodiment, the shearing or scissors action occurs between the distalportions of a first and/or second articulable beaks 516, 518 againstedges of a scoopula portion of an outer sheath 512. However, the firstand second articulable beaks 516, 518 may also be configured to extendfurther out of an outer sheath 512, and in either a closed or open beakconfiguration. A closed beak configuration in which the work elementextends only to the proximal opening of a scoopula of an outer sheath512 may be well suited to advancing through tissue to the intendedlesson site, with a closed first or first and second articulable beaks516, 518 blocking tissue entry into the central lumen as a scoopulaportion of an outer sheath 512 advances through the tissue.Alternatively, such extension of a first and second articulable beaks516, 518 outside of an outer sheath 512 may constitute a phase of acombined rotational/closing and part-off action following coring of thetissue accomplished with a first and second articulable beaks 516, 518at least partially enclosed within an outer sheath 512. Finally,extension of a first and second articulable beaks 516, 518 in either theclosed or open configuration may be accomplished either by extendingthem in the distal direction and/or retraction of a distal sheath 592(as shown in FIG. 20 below), in relation to cored or to-be-cored tissue.To limit the extent of force that, may be applied to the first andsecond tendons 468, 470 and thus on the first and second articulablebeaks 516, 518, the work element 13 may comprise travel limiterstructures 467 (only one of which is visible in FIG. 16B, but alsosimilar in function to that shown above in FIG. 15C, for example).Indeed, as shown in FIG. 16B and according to one embodiment, the travelin the distal and proximal directions of the beak actuating elements 469may be limited by interlocking tab and slot features of various shapesthat only allow a limited relative travel between the constituentelements thereof. Such limited travel is sufficient according to oneembodiment, to fully open and to fully close a first or a first andsecond articulable beaks 516, 518.

The distal free end of an outer sheath 512 may be shaped as desired andmay comprise, as shown in FIG. 16B, a scoopula (or a trowel- ortrough-like, for example) shape. This distal edge may be sharpened, toaid in the penetration into and coring of tissue. Vacuum slots may beprovided within an outer sheath, as shown at 520. Should a vacuum bedrawn within the lumen of an outer sheath 512, surrounding tissue may bedrawn thereto, thereby assisting in stabilizing the distal end of theexcisional device during the specimen cutting procedure. Vacuum slots520 may also serve to collect liquids and free cells from thesurrounding tissue or to deliver liquids to the surrounding tissue. Theymay also serve as an opening at the distal end of the device so mat asvacuum is applied internally at the proximal end of an outer sheath 512as an aid in transporting tissue specimens proximally, a correspondingvacuum is not built up behind (distally to) the tissue specimens.Avoidance of vacuum buildup distal to the tissue specimens mayfacilitate tissue transport in the proximal direction as well as preventtissue specimens from acting as plugs in the work element. Slots mayalso be provided in the trough of a scoopula itself as an aid to imagingdevices to sharpen visibility of a scoopula in relation to surroundingtissues.

The shape of the sharp cutting elements beak (or work) assembly 13, suchas the embodiment thereof shown in FIGS. 1 and 16A and 16B, for example,provides substantial support for all movements required of the cuttingbeaks during rotation, opening/closing and axial motions (not shown).Using the nomenclature of FIG. 1 in particular, this embodiment enablesthe sharp cutting elements of beak assembly 13 to be made extremelythin, which fulfills a requirement mat for any given outer radialdimension of a tubular coring and transport assembly (including thecutting beak assembly) 11 (see also FIG. 1), the caliber of the coresample retrieved from the patient will be as large as possible. Theshape(s) of the sharp cutting elements of beak assembly 13 specified foruse in coring and part-off according to embodiments enable the biopsydevice 10 to core a full diameter, and in fact larger than full diameterwith respect to the dimensions of the coring and transport assembly 11,of which slightly larger caliber (e.g., diameter) may be desirable inorder to compress, “stuff”, or pack in as much tissue sample into thetubular coring and transport assembly 11 as possible, which may proveadvantageous from several standpoints (including diagnostic, clinicalstandpoints) or provide more sample (not shown) for analysis.

According to one embodiment and as described herein, a work element 13of FIG. 1, including articulable beak(s) 516 and 518, or 516 or 518alone of FIG. 16B, may be configured for rotation within an outer non-or differentially-rotating outer sheath(s), such as 512 of FIG. 16B.Moreover, the articulable beak(s), according to one embodiment maycomprise a surface having substantially the same curvature as the bodyportion of the work element 13. The body portion of the work element,may be that portion thereof that is proximal to the articulable beak orbeaks. According to one embodiment, the articulable beak(s) may begenerally described as being or comprising one or more hyperbolicsegments of one or more sections of a hollow cylinder, such as a hypotube. Variations including complex curves may be incorporated into theshape of articulable beak(s) to optimize function in different sectionsof, for example, the edges of the articulable beaks. Moreover, first andsecond articulable beaks, according to embodiments, may have slightlydifferent shapes from one another. The angle formed by the distalportion of first and second articulable beaks or between a singlearticulable beak and a scoopula may be, for example, from about 5 to 75degrees. According to one embodiment, the angle may be between about 10and 30 degrees. According to another embodiment, the angle formed by thedistal portion of first and second articulable beaks or first beak and ascoopula may be about 18 degrees.

Note that, according to one embodiment the entire work element,including a first or first and second articulable beaks 516 and 518 ofbeak assembly 13 along with first and second tendons, beak actuationmechanisms such as 469, living hinges 458 (as best shown in FIGS. 15Cand 16A) connecting a single or first and second articulable beaks tothe body portion of the work element travel limiter structures and, asdescribed below, a first helical element may all together comprise asingle monolithic structure formed of a same material that may be (e.g.,laser-) cut from, for example, a single solid hypo tube. That is, thesestructures may be formed together of a same piece of unbrokenhomogeneous material whether a single split tube is selected or whethera non-split tube is selected, according to embodiments. Such amonolithic structure may be considered to be a monolithic work assembly,and may take the form of a monolithic beak assembly, which is but oneembodiment thereof.

Continuing to describe additional elements of a tubular transport andcoring assembly 11 of FIG. 1, according to embodiments, FIGS. 17A and17B show an intermediate, proximal sheath 540 of an excisional device10, according to one embodiment without showing any additional non- ordifferentially-rotating distal and outer sheaths. According to oneembodiment, a proximal, sheath 540 may be configured to fit over atleast, a portion of a work element 13 (as shown later in FIG. 21) andabut collar 542, which collar may be nothing more than an internalshoulder within a distal sheath 590, such as shoulder 593 in FIG. 20below. According to one embodiment, a proximal sheath 540 may beconfigured to resiliently bias a first and second articulable beak 518or beaks 516 and 518, if twin (or multiple) beaks are used, in die openposition. According to one embodiment, a proximal sheath 540 may be slidover the proximal portion of a work element 13 and then further advancedover the work element 13 until the distal end of the proximal sheath 540abuts against a collar 542 (or shoulder 593 of FIG. 20). Therefore, aswill be described below relative to FIG. 2L selectively acting upon(e.g., exerting a proximally-directed or distally-directed force on) theproximal portion 548 of a proximal sheath 540 causes a first and secondarticulable beaks 516, 518 to open and close. If only one beak ispresent, that beak may be configured to open and close against, forexample, an otherwise immobile scoopula-shaped portion of an outersheath 512, as previously described above. According to one embodiment,a proximal sheath 540 may itself be enclosed by an outer non- ordifferentially rotating distal sheath 590, which effectively capturesthe distal portion 546 of a proximal sheath against an outer sheath 512,as shown in FIGS. 20 and 21 further on. Thus, a proximal sheath may actin concert with a distal sheath 590, as shown in FIG. 20, over at leasta portion of the work element 13 to cause a first and second articulablebeaks 516, 518 to open and close. According to one embodiment, theproximal sheath 540 may be either free floating or driven in rotation,and may be non- or differentially rotating with respect to any outersheaths as described further on. According to another embodiment furtherdetailed below, collar 542, which is primarily shown for illustrativepurposes, may be eliminated and a beak actuating portion 469, as shownin FIG. 16A, and a body portion 428, as shown in FIG. 19, of the workingelement 13 may be directly attached to a proximal sheath 540 at thedistal and proximal ends of a helical portion 544 of the proximalsheath. In such an embodiment, the work element 13 may be attached to aproximal end of such a second helical element 544 to rotate the workelement 13, including a first and second articulable beaks. In thismanner, a proximal sheath 540 may be configured to entrain the workelement 13 in rotation as well as to open and close articulable beaks.In such an embodiment, a first helical element 472, such as previouslyshown in FIGS. 2-6, may be decoupled from the work element 13, therebyenabling a first helical element 472 to be driven at a rotational speedthat is independent of the rotation speed of a connected proximal sheath540 and a first or a first and second articulable beaks 518 or 516, 518,as is shown and discussed in greater detail below. According to oneembodiment to bias a first and second articulable beaks 516, 518 in theopen position, at least partially within an outer sheath 512, accordingto one embodiment, a proximal sheath 540 may comprise such a secondhelical element 544. In this manner, according to one embodiment, sotonly may the present biopsy device comprise a first or a first andsecond helical elements, but such helical elements may be co-axiallyarranged within the device, one over the other. According to oneembodiment at least a portion of a second helical element may fit over afirst helical element within the biopsy device to effectively define astructure comprising a coil-within-a-coil, as shown in FIG. 19.

According to one embodiment, a proximal sheath 540 may comprise aproximal region 548 and a distal region 546 comprising a second helicalelement 544. The proximal region 548 may be generally co-extensive withat least a portion of a first helical element 472, if included in suchembodiment, of the work element and may comprise structure configured toaid in the proximal transport of a severed tissue specimen, indeed,after being severed from surrounding tissue, the cored specimen will beurged in the proximal direction within the body portion of the workelement 13 and eventually engage such a rotating first helical elementif used, or engage a flush conduit that aids tissue transport. A firsthelical element, if present according to embodiments, may assist in thetransport of the cored specimen to, e.g., a tissue collection transfermagazine 27 coupled to the present biopsy device. Surface features maybe provided on the inner lumen of a proximal sheath 540 which, howeverconfigured, may aid in the transport of cored specimen by providing somemeasure of friction between the cored specimen and a rotating firsthelical element 472, if used, to enable the cored specimen to move in aproximal direction through the device. According to one embodiment andas shown in FIGS. 19 and 21 further on, when a proximal sheath 540 isfitted over the work element 13, tissue entrained by a first helicalelement, illustrated by 582 of FIGS. 19 and 22, will also be drawnagainst the inner lumen of a proximal sheath 540. According toembodiments, a flush and a vacuum may be drawn within at least aproximal sheath 540. In this manner, cored tissue specimen(s) may bedrawn through the coils of a first helical element, if present, to comeinto intimate contact with the (e.g., patterned or slotted) surface of aproximal sheath's inner lumen. Alternatively, in other embodiments, onlythe flush fluid and vacuum, acting in concert but without a firsthelical element, may suffice to ensure tissue specimen transport to atransfer magazine. The flush may be provided with flow rates rangingfrom 0 to 100 cubic centimeters per minute. The vacuum may be providedwith a pressure range from atmospheric to 0.001 Torr and may have flowrates ranging from 0 to 200 cubic centimeters per minute.

As shown in FIG. 17A, and according to one embodiment, a proximal sheath540 may define one or more elongated slots 552 therein. FIG. 18 shows aproximal sheath 540 comprising a plurality of elongated slots 552disposed in a spiral pattern around a longitudinal axis and serving as ahelical element according to one embodiment. Such slots 552 may allowfluid communication with the interior lumen of a proximal sheath 540. Inother words, a slot or slots 552 may go all of the way through, the wallthickness of a proximal sheath 540. For example, when vacuum is drawnwithin a proximal sheath, cored tissue specimens being transported by afirst rotating helical element 582, if used, may be drawn to slots 552,and partially invaginated therein, providing some resistance to thecored tissue specimen, thereby preventing them from simply rotating inplace within a first helical element without moving. Slots 552 may alsoserve as conduits for flushing liquids used to aid transport, in concertwith aspiration applied from a vacuum source within or external to thedevice 10. According to one embodiment slots 552 may be seriallydisposed end-to-end substantially parallel to the longitudinal axis of aproximal sheath 540, as shown in FIG. 17A, may be offset relative to oneanother, or may be disposed in a spiral pattern, whether non-overlappingor overlapping, as shown in FIG. 18, thus effectively acting as anelongated co-axially disposed third helical element of similar ordifferent pitch than a second helical element similar to that discussedunder FIG. 17B above.

FIG. 18 shows one embodiment where a proximal sheath 540 includes slots552, as previously shown in FIG. 17A, in an overlapping spiral pattern,which slots 552 may effectively function as a third helical elementco-axially disposed relative to a first helical element 582 and secondhelical element 544. The slots 552, according to one embodiment may beconfigured to provide resistance to the cored tissue specimen to enablea first helical element to transport the tissue specimen in the proximaldirection. It is recalled that a first helical element may be decoupledfrom the work element 13 (including the first and second articulablebeaks), and that a proximal sheath 540 may be mechanically coupled totendon actuating elements 469 (and, also, to a first or first and secondarticulable beaks) to provide both rotational force and beak opening andclosing actuation, as described relative to FIGS. 19 and 21. In such anembodiment, therefore, the relative speeds of rotation of a first orfirst and second articulable beaks and a first helical element may bedriven independently and differentially tuned to optimize both tissuecoring and tissue specimen axial transport in a proximal direction (e.g.to a transfer magazine 27 of a device 10).

FIG. 19 shows details of a proximal sheath, beak actuation elements andan inner first helical element according to embodiments. It is to benoted that the figures herein are not to scale and the relativedimensions of the constituent elements of the biopsy device 10 may varyfrom figure to figure. According to one embodiment, the working end(e.g., substantially all structures distal to the handle 12) of thebiopsy device 10 may be essentially composed or formed of two or moreseparate elements that are disposed substantially concentrically orco-axially relative to one another. This results in a mechanicallyrobust working end of the excisional device that is economical tomanufacture and to assemble.

As shown in tire exploded view of FIG. 19, one embodiment comprises awork element that comprises a body portion 428 and tendon actuatingelements 469 (only one of which is shown in this view), and may beterminated by a first and/or second articulable beaks (not shown in thisview). A first helical element 582 may be formed of the same material asthe work element 13. According to one embodiment, the work element 13(i.e., a body portion 428, a tendon actuation element 469 and a first orfirst and second articulable beaks) and a first helical element may becut or formed from a single piece of material, such as a hypo tube. Forexample, the hypo tube may be suitably (e.g., laser) cut to form thebody portion 428, the tendon actuation elements 469, the first andsecond articulable beaks as well as a first helical element 582. A firsthelical element 582 may then be mechanically decoupled from the workelement 13 by cutting the two structures apart. These two structuresare, therefore, labeled (1a) and (1b) in FIG. 19, to suggest that theymay have been originally formed of a single piece of material. That afirst helical element is mechanically decoupled from the work element 13enables the rotation of a first helical element 582 to be independent ofthe rotation of the work element 13. For example, a first helicalelement 582 may rotate at a comparatively slower rate than the rate ofrotation of the work element 13, as transport of a severed tissuespecimen may not require the same rate of rotation as may be advisablefor the work element 13. According to further embodiments, a firsthelical element 582 may be deleted, leaving an expansion chamber in itsplace, relative to the central lumen inside a proximal sheath 540 (notshown in this figure), since the diameter of a proximal sheath 540 isgreater than the diameter, of the beak assembly 13 to which it may befixed, thus providing an expansion chamber proximal to die proximal endof the beak assembly 13. In such embodiment, a proximal sheath couldextend proximally to a transfer magazine 27 at a vacuum tight junction.

The second of the three main separate elements of the working end of thebiopsy device, in one embodiment, is a proximal sheath 584, as shown at(2) in FIG. 19. A proximal sheath 584 may comprise, near its distal end,a second helical element 585 (similar to 544 of FIG. 18). As shown inFIG. 19, a second helical element 585 may be disposed concentricallyover a portion of a first helical element 582. According to oneembodiment, a proximal sheath 584 may comprise one or more proximallocations 586 and one or more distal locations 587. The proximal anddistal locations 586, 587 may define, for example, indentations,obrounds or through holes and may indicate the position of, for example,spot welds (or other attachment modalities) that are configured tomechanically couple a proximal sheath 584 with the work element of thebiopsy device. When assembled, a proximal sheath 584 may beconcentrically disposed over a first helical element 582, if present insuch embodiment, and advanced such that the one or more proximallocations 586 on a proximal sheath 584 are aligned with correspondingone or more proximal attachment locations 588, if present on the workelement 13 and such that one or more distal location 587 on a proximalsheath 584 is aligned with corresponding one or more distal attachmentlocation 589 on a tendon actuating element 469. The correspondinglocations 586, 588 and 587, 589 may then be attached to one another. Forexample, one or more proximal locations 586 on the proximal sheath 584may be spot-welded to corresponding one or more proximal attachmentlocations 588 on the work element 13 and one or more distal location 587on the proximal sheath 584 may be spot-welded to corresponding one ormore distal attachment location 589 on a tendon actuating elements 469.

It is to be noted that locations 586, 587, 588 and 589 are only shown inthe figures as illustrative and exemplary only, as there are many waysof mechanically coupling or attaching a proximal sheath 584 to the workelement 13, as those of skill may recognize. According to oneembodiment, a proximal sheath 584 may be attached such that movement ofa second helical element 585 (e.g., extension and compression)correspondingly actuates a first beak (and, if present a secondarticulable beak) between a first (e.g., open) configuration and asecond (e.g., closed) configuration. Indeed, a proximal sheath 584 maybe mechanically coupled to the work element of the biopsy device suchthat, for example, a proximal portion thereof (e.g., at or in thevicinity of proximal locations 586) is attached to a body portion 428 ofthe work element 13 and such that a distal portion thereof (e.g., at orin the vicinity of distal location 587) may be attached to a tendonactuating elements 469. In this manner, compression and extension of thesecond helical element 585 may cause a relative displacement of a tendonactuation elements 469 and a body portion 428 (i.e., one may move whilethe other is immobile or substantially so, or both may move relative toone another), thereby causing the actuation of a first or first andsecond articulable beaks.

FIG. 20 shows a non-differentially, or same-speed rotating distal sheath590, (which may also serve as an outer sheath 512, wherein a scoopula ofsuch structure may extend from about 1 millimeter to more than 200millimeters, according to embodiments) which may or may not, accordingto embodiments, extend over a first or first and second articulablebeaks. It should be noted that differential rotation may also imply notonly a difference in relative speeds between two elements, such as aproximal and distal sheath, but also that, the direction of rotation maybe different, according to embodiments. Such opposite rotation serves toincrease the relative concentric rotational speed between the twoelements, while allowing simplification of the corresponding drivemechanisms, which may thus not have to be rotated at the high speedsnecessary to achieve a certain relative speed differential between twosuch elements. The third (labeled as 3 in this figure as its proximalend is of greater diameter than 1 and 2 of FIG. 19) of the three or fourcoring and transport assembly 11 elements, according to certainembodiments, is a distal sheath 590 which may be configured to fit overthe work element 13 as shown in FIG. 19 comprising a body portion 428, atendon actuating element 469 and at least a portion of a first or firstand second articulable beaks. A distal sheath 590 may also be configuredto slide and fit over a proximal sheath 584 that is mechanically coupledto the work element 13. When the distal sheath 590 is combined with aproximal sheath 584 and work element 13, it may be referred to as aninner assembly, which may be fitted into an outer sheath. A distalsheath 590, according to one embodiment, may comprise a distal portion592 (shown extended to the tips of the beaks within, but which may beshortened all the way to just distal of shoulder 593) having a firstdiameter, and a proximal portion 594 having a second diameter. Thesecond diameter may be larger than the first diameter. To accommodatethe differences in diameters of the first and second portions 592, 594,a distal sheath may comprise a shoulder 593 comprising a surface thattransitions between the distal and proximal, portions 592, 594 ofdiffering diameters and against which the distal portion of a secondhelical element 585 of FIG. 19 may act, in one embodiment. Furthermore,a distal sheath such as shown in this figure extended nearly to the tipsof the beaks or only partway along the beak assembly 13 may beconfigured to core forward along the length of the scoopula of an outersheath, such as 512 of FIG. 16B, while lying in the trough of thescoopula, which may be useful in ensuring that any tissue encounteredwould not slide away from the scoopula by combining a forward cuttingand side cutting mechanism as previously discussed herein. The scoopulaside cuts as it is rotated about the clock face in sampling or is movedlaterally to a new target tissue site, and the beak or beaks forward cutas they core within the trough of the scoopula. Furthermore, as thebeaks act against the sides of the scoopula, there exists a scissorsaction between the edge of the scoopula and the beak or beak edgescombine forward and side cutting by combined application of theirindividual cutting surfaces.

According to embodiments, not only a distal sheath, but a proximalsheath and any outer sheaths as well may have shoulders similar toshoulder element 593 of FIG. 20. Such first and second diameter portionsof each of these sheaths may be incorporated to accommodate each otherin configuration, but also to establish a further expanded expansionchamber portion of a proximal sheath 584 proximal to its attachment to amonolithic beak assembly 13. Such an expansion chamber, which may beeven greater than the inner diameter expansion that is simply due to aproximal sheath's greater inside diameter than that of a monolithic beakassembly 13, may similarly serve to allow tissue sample expansion onceclear of the coring and severing beak(s), which may farther aid tissuetransport, with or without a first helical element, and in the presenceof active or passive flush fluids and/or aspiration as primary orsecondary transport aids. Such an expansion chamber may reduce innerwall friction between the tissue sample and the inner lumen of thedevice 10, as well as providing space for flush fluids, either passiveor active in motion, as will be shown in a further illustration below,to aid tissue transport to a transfer magazine 27 of the device, asshown in FIG. 1.

FIG. 21 is a view of a two-beak assembly with both a distal sheath 590and the outer sheath 512 removed, according to embodiments. FIG. 21shows components of the work element 13 (comprising, e.g., a bodyportion 428, one of a tendon actuation elements 469 and a first andsecond articulable beaks 602, 604) mechanically coupled to a proximalsheath 584. To show interior structures, a distal sheath 590 is omittedin this view. As suggested at 586, 588 and at 587, 589, a proximalsheath 584 may be spot-welded to the work element 13 in such a manner asto enable differential motion of a body portion 428 of the work element13 relative to tendon actuating elements 469 thereof when a secondhelical element 585 compresses and extends, which differential motionactuates (e.g., opens and closes) a first and second articulable beaks602, 604. Significantly, the attachment of a proximal sheath 584 to botha body portion 428 and to a tendon actuating elements 469 of the workelement 13 results in substantially equal torque being imposed on theconstituent elements of the work element thereby maintaining thestructural integrity of the work element as it is spun up to speed (byrotating a proximal sheath 584 in this embodiment) and as a first andsecond articulable beaks 602, 604 cut through variably dense, fibrousand vascularized tissues.

FIG. 22 is a view of a configuration of a short monolithic (todistinguish over the split tube long monolithic single beakconfiguration of FIG. 15C, for example) single-beak 604 assembly,according to embodiments. FIG. 22 shows a body portion 428, a tendonactuation element 469 and a first articulable beak 604 of the workelement 13 together with a first helical element 582. A proximal sheath584, a distal sheath 590 and an outer sheath 512 are not visible in thisview. As shown, a first helical element may be co-axially disposedrelative to a body portion 428 of die work element 13 and may be of thesame or substantially the same diameter. As noted above, the two may beformed of or cut from a single piece of material such as, for example, astainless steel hypo tube. According to another embodiment, a firsthelical member may be of a different diameter than a body portion 428.However, such an embodiment may require corresponding changes to thediameters of a proximal sheath 584 and the proximal portion 594 of adistal sheath 590 and a change to a shoulder 593, if present in oneembodiment, such a single beak 604 may act against the side and forwardedges of an outer sheath 512 (not shown in this figure) as illustratedby FIGS. 2-15, according to embodiments. For example, a single beak 604may act against a scoopula-shaped distal end portion of an outer sheathas previously described.

Based upon the principles of distal work element (beaks) operations fromthe previous descriptions associated with FIGS. 16-22, it may be seenthat, according to embodiments, a rotating proximal sheath 584 may serveto both rotate a single or multiple beaks as well as provide themechanism for opening and closing a beak or beaks by being itself movedaxially distally such that its distal end pushes rap against a non- ordifferentially or same speed rotating distal sheath 590, or a rotatingproximal sheath 584 may serve to rotate a single or multiple beaks ofthe work element 13 being attached to a proximal portion of a monolithicwork-element, while an identically rotating distal sheath 590 may beattached to a beak tendon actuation elements 469, whereby the relativeaxial movement of proximal and distal sheaths allows for beak actuation.These structures may be further enclosed by a non- or differentiallyrotating or rotatable and removable outer sheath 512 that may terminate,according to one embodiment, in a trough or scoopula shape, all of whichfor this device 10 are referred to as the tubular coring and transportassembly 11 in FIG. 1. In the inner lumen of this coring and transportassembly 11, a first helical element 582 may be provided to transportcored and severed specimen in the proximal direction, which may befurther aided of replaced by liquid flush induced into the central lumenat the distal end or along the length of the assembly 11 and/or a vacuumaspiration introduced at the proximal end of device 10. If provided, afirst helical element 582 may rotate at a different speed than that of aproximal sheath 584 and the beak element(s) 13. With these principles inmind, the following set of figures addresses the mechanical means ofproviding such actions to the distal end of device 10 of FIG. 1,according to embodiments. It may also be seen that the mechanicalarrangements described herein are not the only arrangements that mayaccomplish some or all of these desired actions on the tubular coringand transport assembly 11, and other arrangements that may be envisionedby a person skilled in the art are considered within the scope of thisinvention.

FIG. 23 shows a top view of a mechanical arrangement for tubular coringand transport assembly 11 rotation and actuation, according to oneembodiment. In this view, an outer sheath 512 is not shown for ease ofillustration, but is shown in FIG. 26A, which illustrates the entiredevice 10, according to one embodiment. From the left or distal side, aproximal end of a distal sheath 590 passes through a front seal, whichin this view is at the distal, end of a housing of device 10. A distalsheath 590 is free to move against an internal spring, axially forwardand back. According to one embodiment, the total distance of suchmovement may be about equal to a maximum sample tissue length (not toscale, all relative distances such as Xmm, Ymm and corresponding Dx andDy (D for distance) are shown for illustrative purposes only). At itsproximal end, a distal sheath 590 may be embedded into a tubesocket/seal 603, which is itself coupled to the forward wall of a distalsheath, earner 606, which may be configured to slide back and forthwithin a slide 605 a maximum distance defined by a carrier stop 604,both of which are formed in the outer housing of device 10 in thisembodiment. Continuing to the right of the illustration, a proximalsheath 584, contained within a distal sheath 590 and rotatingindependently thereof, in this embodiment, may be seen passing, througha thrust bearing 609A in the forward wall of a proximal sheath carrier609. A proximal sheath carrier 609 may be configured to slide axiallyinside a distal sheath carrier on slide 608, which is furnished with itsown spring to effectively allow a return force to separate the two(distal and proximal) carriers if they are pushed together, which causesa proximal sheath 584 to move backward or forward, respectively, inrelation to a distal sheath 590. Recalling that it is the differentialaxial movement between a distal sheath 590 and a proximal sheath 584that activates beak opening and dosing, it may be seen that in suchembodiment, such axial movement may be accomplished by the action of thetwo earners in relation to one another. The total distance travelled bya proximal sheath earner 609 therefore relates to the axial distancetravelled between proximal and distal sheaths to open or close the beakor beaks 13 at the distal end of device 10 according to embodiments.

A proximal sheath 584 is also free to move axially in the distal andproximal directions, under rotation as a result of a thrust bearing 609Adescribed above. A proximal sheath 584 continues proximally in thisillustration through a vacuum seal 612 at forward bulkhead of vacuumchamber 611, which serves to capture any stray fluids that, may not havebeen aspirated through the central lumen of the whole tubular coring andtransport assembly 11 and through a transfer magazine 27. Rotationalforce for a proximal sheath 584 is provided by its gear 614 (which may,according to embodiments, be extended to also rotate a distal sheath 590at the same speed if they rotate together as described in FIG. 22above), in this illustration, which is driven by a proximal sheathpinion gear 613. A first helical element 582 may also be seen in thisfigure, which first helical element 582, if present, may be driven at adifferent rotational speed than that of a proximal sheath by its owngear 616 and pinion gear 615, which may also drive a flush pump orvacuum system of the device (not shown). If such is provided, a firsthelical element may terminate within a transfer magazine 27 in which,tissue samples may be deposited serially.

FIG. 23 also shows that, according to one embodiment, distal andproximal sheath carriers may terminate proximally by vertical side wallsof any shape, and upon which a rotating dual cam gear 620, withindividual cams such, as a distal sheath cam 618 and a proximal sheathcam 619, act upon the vertical side walls of the two carriers. The innerside walls and cam 619 correspond to the proximal sheath carrier 609 andthe outer side walls and cam 618 correspond to the distal sheath carrier606. It may be envisioned, depending on the side profile of each earn,as well as the side profiles of the two vertical side walls, that manydifferent fine-tuned configurations may actuate the same or differentialmovement, acceleration and timing of differential movement of the twocarriers relative to each other, and thus to the combined andcoordinated action of the distal work element of device 10, according toembodiments. For instance, the beginning of the rotation of twin gearcams 620 with their individual cams 615 and 619 may actuate the carriersequally, corresponding to distal-directed movement of distal andproximal sheaths, thus coring tissue with the beaks open and rotating.Upon reaching a certain axial distance, a cam 619 may continue forward,closing the beaks and keeping them closed while both distal and proximalsheaths retreat proximally carrying the tissue sample backwards anddelivering it to a transport mechanism for eventual delivery to atransfer magazine 27. In such an embodiment, gentle traction would beapplied to the tissue sample taken at the end of the part offstage ofthe biopsy device 10's action for that sample, further ensuring apositive part-off from surrounding tissue. Many different cam/camfollower (vertical rear walls of the carriers) configurations or shapesmay be envisioned to provide forward and backward axial movementcombined with differential acceleration of the individual sheaths toallow the device 10 to accomplish its desired operations at differentpre-, intra-, and post-operative stages of penetration, coring,part-off, retrieval and storage of sequential samples, as well asmaterial collection from or delivery to the target site as describedpreviously. For instance, a dimple in the center vertical section of avertical rear wall of an inner carrier would result in a double closingof the beaks after a short time interval, which may result in furtheraiding positive part off of the tissue sample. The vertical walls ofeach carrier may be asymmetrical to each other or in their upper orlower sections, depending on the mechanical effect desired. The camsthemselves may be asymmetrical in their individual side shapes which,combined with special shapes imparted to the vertical rear walls of thecarriers, may enable or result in extremely fine tuning of the carrieraxial movements at any desired point in time, defined by therevolutionary speed and instantaneous radial angle during revolution oftwin cam gears at any time. The twin cam gears of this embodiment may bepowered by a worm gear 621, which may allow for movement of the twocarriers to be frozen in position at any desired stage. The worm gear621 may itself be driven by a pinion gear 623 movable on its pilot shaft624 operating through a simple clutch mechanism 622. It should also benoted that at any time, carrier 609 and carrier 606 may be manuallysqueezed together through a simple mechanical linkage (not shown), whichmay cause the beaks to close and part off or remain closed at anoperator's choice. It should also be noted that rotation and axialmovement are independent of one another with such an arrangement, andthus may be controlled wife different actuation mechanisms to allow thedevice 10 to accomplish all of its intended functions. Again, thisillustration is only one of many different mechanical arrangements thatmay be envisioned by one of skill in the art all of which are consideredto be within the scope of tills disclosure, and feat may be selected toenable the device to accomplish any or all of the following actionsconsidered characteristic of device 10, according to embodiments:

-   -   Penetration to the target tissue site or withdrawal from the        site:        -   Beak(s) closed and withdrawn, no rotation, scoopula in            pre-firing or extended mode;        -   Beak(s) closed and extended, no rotation, scoopula in            pre-firing or extended mode;        -   Beak(s) closed and withdrawn, with rotation, scoopula in            pre-firing or extended mode;        -   Beak(s) closed and extended, with rotation, scoopula in            pre-firing or extended mode;        -   Beak(s) open, either withdrawn or extended, no rotation,            scoopula in pre-firing or extended mode;        -   Beak(s) open, either withdrawn or extended, with rotation,            scoopula in pre-firing or extended mode;    -   Semi-automatic tissue sampling (gear cams stop after one        rotation);    -   Automatic tissue sampling (gear cams continue to rotate until        interrupted);    -   Short core sampling (using the manual part off function        described above); and    -   Continuous core sampling of any sample length, terminating in        manual part off.

FIG. 24 is an illustration of principles of a different arrangement of acam gear and cam follower arrangement according to embodiments. Thisfigure specifically looks at the time-based action of geared cam 620(shown as the central circle in this figure) but configured with twopins surrounded by bushings that act in a similar manner to cams 618 and619 from FIG. 23, and are thus labeled as such in this figure, in thisembodiment, the geared cam wheel 620 is assumed to rotate in a clockwisedirection, with pin 818 (analogous in function to cam 618 of FIG. 23)being a short pin that acts only on the inside proximal sheath carrier'svertical rear walk and pin 619 (analogous in function to cam 619 of FIG.23), which is a longer pin that is capable at times of effectivelyacting on both the proximal sheath earner 609 and the distal sheathcarrier 606 vertical rear walls simultaneously. The arc distance betweenthe two pins on the inner surface of the gear cam wheel shown by the twoangles “a”, using the analogy from FIG. 23, determines which of the twopins is acting on which carrier at any given point in time, eithertogether or in a lead-lag relationship depending on the revolutionaryposition in time of the gear wheel as it rotates. For purposes ofillustration, the larger arcs scribed in this figure correspond to thevertical rear wall surface of the distal sheath carrier 606, and thesmaller scribed arcs correspond to the vertical rear wall of theproximal sheath carrier 609. The pins 615 and 619 are shown with theirbushings only at the start of the cycle, for purposes of illustration,and are shown as dots at various other locations which correspond totheir movement at various time intervals with gear cam wheel 620. Thegear cam wheel 620 is shown to the right of the figure, with the arcs ofthe carriers extending to the left to correspond with the independentcarrier movement outlined in the previous FIG. 23. It can be seen thatthe longer pin 619 is a shorter radial distance from the center of thegear cam wheel 620 than the short pin 618, which pin 618 acts only onthe proximal sheath carrier 609. The short pin 618 is also lagging thelong pin 619 in revolutionary time, which implies that it comes intoplay only at a certain point in the clockwise movement of the gear camwheel 620. Recalling that if the proximal sheath is pressed fartherdistally than the distal sheath carrier at any time (even manually bythe operator) with such an embodiment the beak(s) will tend to close,following the principles outlined in previous figures, that at a certainpoint in time (at approximately the 8 o'clock position in this figure)the short pin will begin to act independently on the proximal sheathcarrier and extend it differentially farther distally than the distalsheath carrier, closing the beak(s) and keeping them closed until thatpoint in time (at approximately the 2 o'clock position in thisillustration) when the beak(s) will again open in anticipation ofanother forward excursion of both, proximal, and distal sheaths forcoring and sampling.

For purposes of illustration, it is assumed that the rest position ofthe two carriers is when the long pin 619 is in the 3 o'clock position(beak(s) are open (labeled as “A” or zero time in terms of rotationtime), both distal and proximal sheath are at their closest proximalpoint to the housing of biopsy device 10). The figure includes a smallmicroswitch 632 with a pointer on the gear wheel, whose function could,be to stop/restart gear wheel 620 revolution when the long pin 619 is inits-starting 3 o'clock position, which action may correspond to thedifference between semi-automatic (one revolution and microswitch stopsrevolution until re-enabled) and fully automatic (microswitch disabledaltogether and thus rotation and sampling continues until operatorinterruption of the process) sampling action of the device 10, accordingto embodiments. The total excursion time of the distal end of the device10 (coring forward, part off, sample retrieval and transfer to thetransport mechanism, return to starting position) occurs in a singlerevolution of the gear cam 620, and the individual actions of the pinson the individual sheath carriers 606 and 609 are as described herein.Such total sample (excursion) time may vary from as little as about 2seconds to as long as about 12 seconds, depending on embodiments, with anominally designated time of 4 seconds, in one embodiment. If the totaltime for rotation is assumed to be about 4 seconds, then rotationalposition “A” corresponds to zero, position “B” corresponds to one secondelapsed time, position “C” to that interval when the short pin takesover and the beak(s) begin to close, position “D” to two seconds elapsedtime (and wherein the beak(s) have closed, completely as the short pin618 reaches that position), position E to three seconds elapsed time andthe return to position A corresponds to four seconds total rotationtime, assuming constant speed of gear cam wheel 620, which may also bevariable, according to embodiments. With the long phi at the 3 o'clockposition, it is acting on the vertical rear wall edges of both carrierssimultaneously, which continues to be the case until the long pin 619has reached approximately the 9 o'clock position, at which time theshort pin 618, lagging behind at a calculated arc distance a and furtherradially than the long pin, will start to engage only the inner proximalsheath carrier vertical rear wall, continuing its forward traverse atthe moment when die distal sheath, carrier has ceased its maximumforward or distal movement.

The result is that the beak(s) will close, and remain closed until thelong pin reaches approximately the 1 o'clock position, thus withdrawingthe sample raider either continuing proximal sheath rotation or not, asdesired and according to embodiments (since rotation action of theproximal sheath, which rotates the beak(s) and forward/rearwardexcursion of the carriers are independent of one another, as illustratedin FIG. 23). As the long pin 619 reaches the 3 o'clock position, thebeak(s) are fully open and ready for coring forward again and partingoff and transferring another sample to the transport mechanism andultimately to transfer magazine 27. Of note is that according toembodiments, sampling cycle time is a function of the time of onerevolution of the gear cam wheel 620, and that the timing for beakactuation is a function of the placement of short pin 61S in relation tolong pin 619. The arched (in one embodiment) configuration of thecarrier vertical rear walls is only one configuration, but differentprofile shapes of each vertical rear wall will tend to accelerate ordecelerate the actions of the pins on those surfaces, and many differentvertical rear wall profile shapes are possible, depending onembodiments. Additionally, the profile shapes of the vertical rear wallsof the carriers may differ from top to bottom to impose time-basedfactors on the action (axial movement, with, implied beak actionsassociated with such excursions of the two carriers, in relation to oneanother) of each individual carrier 606 or 609, according toembodiments. Finally, in this illustrated embodiment, the axial distancehorizontally between the short pin 61S and long pin 619 corresponds tothe axial relative distance (and, therefore, time) necessary for travelof the proximal sheath carrier 609 compared to the distal sheath carrier606 in order to accomplish beak(s) closure (or opening, both shown as“b” in this figure and as shown and discussed in FIGS. 19, 21 and 22above.) Total excursion distance of the distal end of device 10 is shownas “c” in this figure, and is a function of the placement of pins 618and 619 and the diameter of the gear cam wheel 620, in one embodiment.Such total excursion distance may be of any length desired, according toembodiments, and for one embodiment, such distance is nominally 1 inchor 2.54 centimeters, corresponding to maximum automatic sample length.Again, it should be noted that samples of any length may be obtained bythe operator with device 10, as will be discussed further below.

FIG. 25 is a side view of a cutting element actuation mechanismconsisting of twin inner and outer sheath carriers, such as 606 and 609of FIG. 23, according to embodiments. From the preceding FIGS. 23 and24, it may be seen that rotation of gear cam wheel 620 will slide bothcarriers axially distally and proximally, in differential movement toeach other, as previously described. Also shown in this figure is thedistal sheath 590 with its external return spring, a distal sheathsocket and optional flush port 603, the proximal sheath 584, theproximal sheath thrust bearing 609A, the gear cam wheel 620 with itsshort bushed pin 618 and its long bashed pin 619, the gear cam wheelmicroswitch 632 and the maximum forward travel proximal sheath carriermicroswitch 633. In the embodiment shown in this figure, the verticalrear walls of each carrier 606 and 609 are profile shaped ashemi-circular in form, and of nearly the same size, although otherembodiments may alter the shapes of either carrier rear vertical wall tobe of any shape desired, which will affect the action of the twocarriers' axial movements, according to embodiments and as describedunder FIG. 24. The rear walls may have special features, such aselliptical shapes in their upper or lower halves, dimples, wavy shapesor any other shape desired, and one skilled in the art will recognizethat such profile features will act with the pins of the gear cam wheelto accelerate or decelerate the individual axial movements of the twocarriers in relation to each other, all such designs and correspondingmovements of which are considered to be within the scope of thisinvention. Further, the profile shape of each of the two carriers maydiffer from each other, and the rear walls may be lowered in relation tothe long horizontal axis of each of the carriers, resulting in acantilevered action on the carriers as imparted by the gear cam wheel620. This may be especially important for embodiments of device 10specifically designed for stereotactic table use, where keeping thecoring and transport assembly 11 of FIGS. 1 and 26 as near as possibleto the upper end of the device as possible may be of benefit in allowinga “down the barrel” view of the device in action, as well as for imagingmechanisms where such a benefit has use in being placed as closely aspossible to the long axis of the working end. (distal end) of the biopsydevice, according to embodiments.

FIG. 26A is a side view of internal and external features and elementsof a biopsy device 10, and FIG. 26B is a front end-on view of a shape ofa biopsy device 10, according to embodiments. In this figure, themechanism of a distal sheath carrier 606 and a proximal sheath carrier609 with their elements of FIGS. 23, 24 and 25 are shown in near scalesize, according to embodiments, and are themselves carried by and slideaxially within drive mechanism earner 640. An outer sheath 512 may beheld to the forward bulkhead of drive mechanism carrier 640 in a mannersimilar to the way that distal sheath 590 is socketed to distal sheathcarrier 606, but is also easily removable from the device 10 by theoperator if desired prior to, during or at the end of a procedure, thusbeing placed or left in situ for the purposes of pre or post-procedurecavity (target tissue site) access for such purposes as the introductionof markers, medications or filler materials as well as drainage or as anintroducer for additional devices. If it is placed pre-procedurally, itmay be placed over a locating wire and serve itself as a locating tubefor device 10 or other devices. It may also have external features tosupport an extendable locating wire or other structure designed toimprove visibility of the tip of the device, immobilize a target tissueor measure its extent, among other functions. An outer sheath 512 may beeasily coupled to a handle 12 or housing of device 10 by a Luer locksystem, for instance and in one embodiment, which would, allow for easyassembly and dis-assembly, as well as for the connection of additionaldevices for fluid or solid delivery systems, drainage systems and otherdevices. Other elements also shown in various previous figures hereininclude a tubular coring and transport assembly 11, a non- ordifferentially rotating or rotatable outer sheath 512, a work elementwith its beak(s) 13, a distal sheath 590, a proximal sheath 584, adistal sheath earlier 606, a proximal sheath carrier 609, a proximalsheath thrust bearing 609A, a distal sheath socket/Hush port 603, aproximal sheath pulley 614 (analogous to gear 614 of FIG. 23, as willalso apply to other pulleys in this figure, which correspond to variousgears of FIG. 23), a first helical element pulley 616, a vacuum chamber611, a first, helical element or transport helix 582, if presentaccording to embodiments, a transfer magazine 27, a flush port 638, anaspiration/material delivery port 639, a power switch/indicator 635, aDC adapter port 637, a DC motor 636, a transport helix pinion pulley615, a proximal sheath pinion pulley and clutch mechanism (magnetic orotherwise) 613, a worm gear clutch pinion pulley 623, a worm gear clutch622, a worm gear clutch (gear cam wheel clutch) button 634, a worm gearpinion 621, a gear cam wheel 620, a drive mechanism carrier commondriveline 641, a return spring 642, a forward firing mechanism triggerand lever 631, and a depth stop adjustment mechanism 630. It should benoted that, according to embodiments, many other substitutions for anyor all of the elements noted herein that accomplish the same function orfunctions may be devised by one skilled in the art, and all suchsubstitutions are considered within the scope of this disclosure. Thedrive mechanism carrier may be used to slide nearly all of the internaldrive components illustrated in this figure forward against a stop atthe distal end of the handle 12 of device 10, which may correspond to aninternal forward firing mechanism for placement of an outer sheath andscoopula portion of an outer sheath 512 in proximity to or through, alesion, as desired by the operator, and as described for such aprocedure in FIG. 1 above. Alternatively, only the outer sheath itselfmay be forward fired without carrying the internal drive mechanism withit according to embodiments. This outer sheath may be manually, or inother embodiments, automatically rotated to various “o'clock” positionsby the operator through a simple manual or driven wheel or ratchet,mechanism attached to an outer sheath 512 (not shown). It should benoted that according to embodiments, rotation of a proximal sheath, afirst helical element, if present, and a distal sheath (if rotated) areindependent of the distal and proximal axial movement of the tubularcoring and transport, assembly 11, and because of mat feature, accordingto embodiments, the operator may select various functions of the device10 at any time, as described previously under FIG. 23 above.

FIG. 26B is an end on view of a biopsy device 10, according to oneembodiment. Various other end profile shapes are possible, and areconsidered within the scope of this disclosure. Of particular note withthis view and this embodiment, the device 10's tubular coring andtransport assembly 11 is located near the very top of the device, whichmay thus allow a better viewpoint for both the operator and the imagingdevices used with device 10.

FIG. 26C shows a transfer magazine 27, according to one embodiment. FIG.26D is a cross-sectional view of a transfer magazine 27 of FIG. 26C,taken along cross-sectional line AA′, and FIG. 26E shows a view of aninternal collection tube that may be split open as shown therein.Considering now FIGS. 26C, 26D and 26E collectively, a transfer magazine27 may contain an internal elongated tube 422 (as shown in FIG. 26E)configured to receive cored and severed tissue specimens. In particular,a transfer magazine 27 may be configured to receive and (e.g.,temporarily) store cored tissue specimens or samples, and to preservethe order in which the samples were acquired. Specifically, a transfermagazine 27, according to one embodiment, may be configured to store aserial train of tissue samples, from a first sample at one end of theserial train of samples to the last sample acquired at the opposite endof the serial train of samples. For example, the first sample taken maybe urged within an elongated tube 422 to be closest to the distal end ofa transfer magazine, wherein proximal and distal qualifiers are definedrelative to the biopsy device. As shown in FIG. 26A, the distal end 406of a transfer magazine 27 is closest to the beak assembly 13 and theproximal end 404 of a transfer magazine 27 may form one of theproximal-most structures of the present biopsy device.

A transfer magazine 27 may address various clinical needs by enablingthe operator of the present biopsy device to inspect the core samplesmore closely, and in some cases tactilely, without destroying therecord-keeping function of transfer magazine 27. A transfer magazine 27is referred to as such, as the storage of the cored and severed tissuesamples may be short term. Since transfer magazines 27, according toembodiments, may be configured to be removable and/or replaceable at anytime(s) during the procedure, the present biopsy device enables avariety of procedural methods to be carried out, which methods would notbe possible, or at least would be impractical, without the structuresdisclosed herein. For example, using the present biopsy device, aclinician may segregate the contents of one transfer magazine 27 fromthe contents of another, additional transfer magazine 27. The operatorof the present biopsy device may also have the ability to interruptcoring/transport/storage with another function of biopsy device, all thewhile, at the operator's discretion, keeping the present biopsy device'stubular coring and transport assembly 11 in place, or alternativelyelements of such assembly 11, such as a removable outer sheath 512, thusminimizing trauma associated with repeated removal and insertion of thepresent biopsy device.

According to embodiments, a transfer magazine 27 may comprise a singleor multiple piece assembly which may include a tube or tubes 422extending forward inside the device all the way distally to monolithicbeak assembly 13, in place of a first helical element 582, oralternatively may extend only to the proximal end of either a proximalsheath 584 as shown in FIG. 26A or to the proximal end of a split tubelong monolithic beak assembly such as shown in FIG. 15B, and may alsocontain slots arranged to allow for flush systems to direct fluids insuch a manner as to aid transport of the tissue specimen and alsocollect body fluids for subsequent analysis. In such embodiments, flushfluids and aspiration by vacuum, would enable continuous transport ofspecimens from the distal end of the device to the main body of atransfer magazine 27, and a transfer magazine 27 may either be separatedfrom its distal transport tube, if present, according to embodiments, orremoved from the device with its integral transport tube. Such a systemwould maintain vacuum integrity within such simple mechanisms from thedistal end of the device to its most proximal end.

An elongated tube 422, according to one embodiment, may also comprise acentral track or inner transfer magazine track, such as shown in FIG.26E below, configured to receive the serial tissue specimen, and,according, to embodiments, may be fitted with a Luer-lock type fittingfor easy attachment, to the device. Vacuum may be provided via an axialvacuum port for instance in the expanded region of FIG. 26C at thedistal end of the magazine, which may allow for only one vacuumconnection to be required by the device, according to embodiments. Atregular intervals (on the order of the length of tissue samples acquiredby the excisional device, for example) along the length of an innertransfer magazine track, the present, transfer magazine 27 may definevacuum holes through which a vacuum may be drawn between the outer tube402 and the inner tube 422, which receives the samples in serial order.According to embodiments, these vacuum holes may be lined with a filterelement, such as sterile filter paper or other filter media, to catchand filter cells and other materials from any fluids that accompany atissue sample to the transfer magazine. This vacuum, optionally alongwith flush, may urge the cored and severed tissue specimen in theproximal direction, towards the proximal end 404 of a transfer magazine27. Having reached the proximal end of the interior track, the cored andsevered tissue specimen may come to rest and may, according to oneembodiment, block or occlude one or more vacuum holes disposed along thelength of an elongated inner tube 422. In this manner, no further vacuumwill be drawn through such blocked vacuum hole(s). This blocked vacuumhole or holes, however, keeps the just-obtained tissue specimen in place(at the proximal-most available slot along the interior track of themagazine 27) while allowing more distally-disposed vacuum holes tocontinue to draw the vacuum therethrough and to continue to urgelater-obtained samples to the next-distal position within the magazine.According to one embodiment, when the last vacuum hole disposed alongthe length of the elongated tube 422 has been blocked by an obtainedsample, a transfer magazine 27 may be considered to be full. A foiltransfer magazine 27 may then be withdrawn from the biopsy device. A newtransfer magazine 27 may then be provided and inserted into the biopsydevice to continue the procedure, if desired. Note that a transfermagazine 27 may be withdrawn from and replaced back into, the biopsydevice, without interrupting the procedure and without withdrawing thework element 13 from the tissue. Moreover, withdrawing a transfermagazine 27 allows access to the interior lumen of the beak assembly,which in turn allows any number of imaging materials or devices,cosmetic materials or therapeutically-beneficial substances to bedelivered, or fluids and/or cells to be evacuated from the target site.

Once a magazine 27 is withdrawn from the biopsy device, a magazinecapping and sealing element 408 may be coupled to the distal end of themagazine 27. A capping and sealing element 408 may be configured to sealthe collected samples, cells and any fluids collected from the outside,to enable ready transport, imaging, direct visual observation or eventactile manipulation. A capping and sealing element 408 may comprise afluid release element 410. A fluid release element 410 may comprise, forexample, an ampule of fluid surrounded and sealed within a soft coveringof, for example, rubber or vinyl. The soft covering may be squeezedbetween the user's fingers to crush the ampule of fluid, which fluid maymen be released to permeate the interior of a transfer magazine 27. Forexample, the fluid, released may comprise a preservative configured topreserve the tissue architecture and prevent degradation of thecollected tissue samples. Other fluids (e.g., stains) may be addedthereto or used in place of the preservative.

According to one embodiment shown in FIG. 26E, a transfer magazine 27inner track, as described in the previous paragraph, may comprise aclam-shell structure. Indeed, a transfer magazine 27 inner track maycomprise a (living, for example) hinge 414 so as to enable the transfermagazine 27 to be opened along its longitudinal axis and its contentsdirectly viewed by the user or pathologist. In such an opened state, atransfer magazine enables any one or all of the samples to be withdrawnfrom a transfer magazine 27 for close examination and, if desired,replaced therein, without disturbing the sequential order in which thesamples were stored. According to embodiments, a transfer magazine 27may comprise visible markings and/or radio opaque markings 412, toassist the user in determining the order in which the samples wereobtained. Such markings may, for example, comprise numbers oridentifying features appearing on the elongated tube 422. For example,the number “1” may be visible in the proximal-most position of a samplewith a transfer magazine, followed by “2” for the location of the nextspecimen, and so on. It is then easy to correlate the specimen with thelocation from which the specimen was taken. For example, if 12 specimenswere taken “around the clock”, the first specimen will correspond to the12:00 o'clock position and the 7^(th) sequentially disposed specimenwithin a transfer magazine 27 will correspond to the 6:00 o'clocklocation with the body. Alternatively or additionally, visible markings412 may consist of metric or imperial ruled markings for ease of samplelength measurement, and may also be radio-opaque or embossed withindividual transfer magazine numbers to distinguish multiple magazinesfrom each other. Part or all of a transfer magazine 27 may comprise orbe formed of transparent material, so as to enable direct visualizationby the user of the obtained specimen. A transfer magazine 27, accordingto embodiments, may be lucent to other imaging modalities, such as MRI,for example. The vacuum holes disposed along the length of the elongatedtube 422 are visible in this view at 416. In an embodiment, features maybe included within a transfer magazine 27, for example on outer tube402, that could be configured to magnify and/or illuminate the acquiredspecimens. Fin-like extensions 418 may be provided, to enable an openedtransfer magazine 27 to lie in a stable manner against a flat surface.Such fins may be asymmetric relative to each other to aid in stabilityof the device when placed upon an unstable or irregular surface. Atransfer magazine may be provided with snap or interference fittings 420to enable a magazine 27 to be manually opened and closed andreopened/reclosed.

According to one embodiment, a tissue biopsy method may compriseperforming coring/biopsy/transport cycles as described above.Thereafter, removing a transfer, magazine and/or proceeding to markingand/or treatment phases may complete the procedure. A transfer magazinemay then be removed and, if desired, placed under X-Ray, magneticresonance imaging and/or ultrasound transducer or high-resolutiondigital camera if a transfer magazine is made of a transparent material.The core tissue specimens may then be imaged/recorded. The magazine maythen be placed in a delivery receptacle, sealed and delivered to a labfor further analysis, making note of core lengths and correlating withimaging record(s) in-situ and ex-vivo. Upon removal of transfer magazine27 from the present biopsy device, the collected cores may then bevisually inspected through the transparent walls of a magazine. Themagazine may then be split open to manually handle and analyze thetissue specimens as desired as well as to collect any fluids or cellsfor cytologic analysis. The magazine may then be closed again, with thespecimen therein.

A transfer magazine 27 may then be replaced with additional emptytransfer magazine(s) as needed to complete the biopsy procedure.Alternatively, other cartridges/magazines may be fitted to the presentbiopsy device to deliver medications, markers and/or tracer elements,therapeutic agents, or therapeutic and/or cosmetic implants to thebiopsy site. Still other devices for imaging or therapeutic purposes mayalso be placed into the device in place of a transfer magazine, asdesired and according to embodiments. The procedure may then beterminated or continued, such as would be the case should thepractitioner desire to biopsy/core other nearby areas as deemedclinically useful.

As shown, a device 10 with, an outer sheath 512 with a scalpel-likedistal end may be gently placed in proximity to or through a lesion, ormay be forward-fired through the lesion using the internal mechanism ofdevice 10, according to embodiments. Clinically and procedurally, theability of a biopsy device to advance gently towards a target lesion,provides several advantages. Indeed, when a biopsy device does notadvance gently toward a target lesion or does not smoothly core throughdense target tissue, the operator may be led to exert excessive forceonto the biopsy device, thereby potentially forcing the biopsy deviceinto and even through adjacent structures. There have been instances ofbiopsy device components being broken off, requiring surgical removalthereof from the biopsy site when excessive force was needed in attemptsto obtain core samples from tissues such as dense breast tissue. Thepresent method of introducing a sharpened scalpel-like scoopula, withthe withdrawn and closed beak(s) configured in a penetration modeaccording to one embodiment herein and provided for with a specificcycle stage in the biopsy device 10 of FIG. 1, enables an operator togently and smoothly approach a target lesion without requiring excessivemanual axially-directed force to be exerted on the present biopsydevice, by the operator or by the stereotactic table itself, if used. Itis to be noted that when excessive force must be exerted to advanceconventional coring devices through dense tissue, the resultant imageprovided by guidance modalities may be significantly distorted by theeffects of the applied force onto the conventional coring device andtransferred to the surrounding tissue, which may cause the resultantimage to be less distinct or blurred, which, in turn, makes the biopsyprocedure less accurate and much more difficult technically. Thisexcessive force may also damage tissue, resulting in loss of tissuearchitecture and production of the aforementioned biopsy artifact. It isan important goal of all core biopsy procedures to firmly establish thatthe core sample is taken from the highly specific image area,notwithstanding the constraints imposed by the small dimensions of thetarget tissue. Such small dimensions, therefore, require clear views ofsharp margins to attain the kind of accuracy desired.

Flush and liquid/solid materials delivery mechanisms may be incorporatedinto the biopsy device 10, according to embodiments, to aid in tissuespecimen transport to the transfer magazine 27. Such mechanisms mayconsist of the distal tube socket/flush port 603 of FIG. 23, which maydeliver flush fluids to the distal end of the device between the distaland proximal sheaths, or similarly with another analogous port betweenthe distal sheath and outer sheath 512, with flush fluids beingconnected to the device through port 638 of FIG. 26A, for example. Flushfluids and other materials may also be delivered to the tissue sitethrough the central lumen of the device, with beak(s) closed (asdescribed for liquids under FIG. 5 above through the living hinge slots)or open, using the aspiration port 639 shown in FIG. 26A or through atransfer magazine 27 of FIG. 1 above, according to embodiments. Flushfluids may also be delivered to the distal tip through ports is thecollar 593 of the distal sheath shown in FIG. 20 above. As previouslydescribed, fluids, solids and other materials may be delivered to thetissue site through the central lumen of the device and various slotsand mechanisms such as the open beak(s) may be used in conjunction withflush fluids to gather and transport cells and liquids from the tissuesite for later cytological analysis.

FIG. 27A is a first view of a stereotactic table adapter for a biopsydevice, according to one embodiment. FIG. 27B is a second view of astereotactic adapter for a biopsy device, according to one embodiment.In FIGS. 27A and 27B, reference 270 denotes some type of genericinterventional device. Reference numeral 278 represents the distal endof the excisional device, whereas numeral 277 represents the proximalend of the generic device 270. For example, 277 may represent a sourceof vacuum. The distal tip of 278 may be provided, for example, with amonolithic beak assembly, as described and shown herein. The excisionaldevice 270 may rest upon stereotactic platform 276, which may be coupledto the stereotactic table stage. According to one embodiment, anexcisional device according to one embodiment or most any excisionaldevice may be coupled to the stereotactic platform 276 through one ormore capstan assemblies 272, 274. One or more of the capstan assemblies272, 274 (or windlass assemblies, by virtue of their horizontal axes),may be provided to enable the user to change the orientation or angle ofattack of the excisional device 270 relative to the platform 276 andthus relative to the stereotactic table stage as well. The capstanassemblies 272, 274 may be, according to one embodiment, secured to boththe excisional device 270 and to the platform 276. That is, dependingupon the orientation of the constituent elements thereof the capstanassemblies 272, 274 may enable one or both ends of the excisional device270 to be moved along the x-y plane (e.g. up and/or over a devicepenetration axis along z). In so doing, the proximal end of theexcisional device may be raised and/or moved off-center relative to theplatform 276, by manipulating the capstan assembly 272. Similarly, thedistal end of the excisional device may be raised and/or movedoff-center relative to the platform 276 by manipulating the distalcapstan assembly 274. Both the proximal and the distal ends of theexcisional device 270 may be raised or moved off-center; either in thesame or different manners. This enables flexibility and fine-grainedcontrol of the orientation of the excisional device 270 independently tothe orientation of the stereotactic table stage, or in conjunction withit, as small adjustments in the orientation of the proximal end of thedevice have a correspondingly larger effect at the distal end (i.e.,working end) of the device 270. In turn, this may enable the user toexert great control of the location within the body from which thesamples are cored and severed (or ablated, dissected, etc., dependingupon the nature of the excisional device 270).

During operation, the user may adjust the orientation of the device 270by turning an actuator such as ship's wheel 271 of the capstan assembly272 in either of the directions indicated at 273 and/or by taming ship'swheel 279 of capstan assembly 274 in either of the directions indicatedat 275. The capstan assembly 272.may be operated using other forms ofactuators. Moreover, such an actuator need not be operated by rotation,as is the ship's wheel 279 shown and described herein, as those of skillin this art may realize. By turning the ship's wheel 279 in this manner,the user may selectively move the proximal end of the device and/or thedistal end thereof up and off-center (relative to its initial centeredposition shown in FIGS. 27A and 27B.

FIG. 27C is a side cutaway view of a platform, suitable for astereotactic table stage, on which an excisional device 270 may becoupled according to one embodiment. As shown, the platform, similar infunction to element 276 of FIGS. 27A and 27B may comprise an upperadapter plate 360 and a lower adapter plate 358. The lower adapter plate358 may be coupled, at 362, to the stereotactic table stage 364. Thelower adapter plate 358, therefore, may be held immobile with respect tothe stereotactic table stage 364. The upper adapter plate 360 may bemovably coupled to the fixed lower adapter plate 358 through, forexample, two or more pivot arms 357. Therefore, the upper plate 360, towhich the excisional device 270 is fixed, may move relative to the loweradapter plate 358. As shown, each end of the upper adapter plate 360(and thus the excisional device 270) may move somewhat independently ofthe other end of the upper adapter plate.

As shown in FIG. 27C, each of the upper and lower adapter platescomprise descending extensions with the lower adapter plate 358comprising the inner descending extensions and the upper adapter plate360 comprising the outer descending extensions that are generallyparallel to the descending extensions of the lower adapter plate 358.According to one embodiment, the capstan assemblies 272, 274 of FIGS.27A and 27C may be fitted in the space between the descending extensionsof the upper adapter plate 360 and the descending extensions of thelower adapter plate 358. According to one embodiment, the capstanassemblies 272, 274 may be fitted over respective central pins of thelower plate 358 such that the ship's wheels 271, 279 are coupled to thedescending extensions of the lower adapter plate 35$. According to oneembodiment, and as is described further relative to FIGS. 28A-D,rotation of the ship wheel 271, 279 thus moves the upper plate 360 (andthus the excisional device coupled thereto) through its foil range ofmotion as the fixed central pin 355 of the lower plate 358 is acted uponby an outer wheel of the capstan assembly 271, 279. In such anembodiment the ship wheels 271, 279 are placed well below the biopsydevice 270, and thus such a system of upper and lower adapter plates maybe fitted to and used with any existing stereotactic biopsy device sincethis embodiment merely fits between and mates to both a biopsy device270 and a stereotactic table stage 364, as well as with the biopsydevice of the present disclosure.

The stereotactic devices commonly encountered today take a series ofbiopsy samples starting with an initial sample, with subsequent samplesbeing taken by manually rotating the outer sheath of the distal end ofsuch devices in a manner so as to sample “around the clock.” The capstanassemblies 272, 274 allow for additional movement of any stereotacticbiopsy device in a greater range of motion than is currently availablethrough the use of the stereotactic table stage controls for x, y and zplacement of the device. Of note also is that the proximal and distalcapstan assemblies 272, 274 may not only be rotated in synchronism withone another but also may be rotated differentially relative to oneanother, such that angles can be obtained in addition to displacement.Such movements may be accomplished by manual manipulation but may alsobe directed by software executing within a stereotactic biopsy devicecontroller. The ability to rotate the two capstans 272, 274independently or in synchronicity enables an interventional radiologist,to gain access to otherwise difficult anatomical locations withoutrepositioning the breast, for example. In effect, the addition of one ormore capstan assemblies 272, 274 add polar coordinate orientationcapability to an otherwise Cartesian-restricted machine, and vice versa.

FIGS. 28A through 28D show one embodiment of a capstan assembly, such asshown at 272 and 274 in FIGS. 27A-C. As shown in FIG. 28A, a capstanassembly 272 may comprise a ship's wheel 271 fitted with extendingprehensile features 372 around the circumference thereof, to enable, theuser to easily turn the ship's wheel 271 about a central pin of thelower adapter plate 338 of FIG. 27C, for example, which is configured tofit within central well 370, to enable the ship's wheel 271 to rotatethereabout. The ship's wheel 271 may comprise a wheel guide extension374, disposed between the central well 370 and the outer circumferenceand substantially parallel to the wheel central well 370. A notchedinner washer 375 may fit over the wheel well 370, such that the wheelguide extension 374 fits within the notch of the inner notched, wheel375. A spiral-path element 376 may then be disposed over the wheel guideextension 374 such that the wheel guide extension 374 fits within thespiral pathway 377 disposed within the spiral guide element 376, asshown in the top view of FIG. 28B.

As shown in FIG. 28C, when the ship's wheel 271 is rotated relative tothe spiral guide element 376, the wheel guide extension 374 travelswithin the spiral pathway 377 defined within the spiral path element376, which may be coupled to the upper adapter place 360 of FIG. 27C,for example. In so doing, the spiral guide element 376 is shifted awayfrom the substantially centered configuration shown in FIG. 28C to themore eccentrically-disposed configuration shown in FIG. 28D. That, is,when the wheel guide extension 374 is disposed within the spiral pathway377 closest to the central well 370, the spiral path element 376 issubstantially centered on the ship's wheel 370, as shown in FIG. 28C. Inthis configuration, the upper adapter plate 360 is in a first, initialconfiguration. As the ship's wheel 271 is turned and as the wheel guideextension 374 travels within the spiral pathway 377, the spiral pathelement 376 deviates more and more from its initial centered position toan eccentric position relative to the wheel well 370, as shown at FIG.28D. At its outermost position within spiral pathway 377, the wheelguide extension 374 forces the spiral path element 376 some distance inthe x-y plane (see FIG. 27A), to thereby force the upper adapter plate360 to correspondingly move the same amount along the x-y plane. Theamount of eccentricity of the spiral path element, (and thus movement ofthe upper plate 360 relative to the lower plate 358) may be readilyadjusted by the user by fine-tuning the turning of the ship's wheel 271,as well as by simultaneously manipulating either or both capstanassemblies with the stereotactic table stage x,y,z controls as describedabove in paragraph 62.

Turning now hack to embodiments of the present excisional device, it isto be noted that, herein, the phrase “helical element” and the terms“helix” or “helices” are intended to encompass a broad spectrum ofstructures. Indeed, the structures shown herein are but possibleimplementations of a helical element, helix or helices. According toother embodiments, “helical element”, “helix” or “helices” andequivalent expressions may be implemented as tubes having one or moreslot-shaped openings or fenestrations along at least a portion of thelength thereof. Such fenestrations may be substantially parallel to thelongitudinal axis of the tube or may be disposed, for example, in aspiral configuration. Hie fenestrations may be continuous along at leasta portion of the length of the tube or may be discontinuous, such as toresult in a plurality of such parallel or spirally wound fenestrations.The fenestrations may be very wide such that the resultant structureresembles a spring, or more narrow, such that the resulting structuremore closely resembles a tube having narrow, slot-shaped openingstherein. The continuous or discontinuous fenestrations may be caused toassume other configurations along at least a portion of the tubes inwhich they are formed. For example, the fenestrations may be caused toform a zigzag pattern such as “NNNN . . . ”, “

” or “VVVV . . . ” or a cross-shaped pattern, such as “XXXXX”.Significantly, the terms “helical element”, “helix” or “helices” shouldbe understood to cover a spectrum of structures, from a spring-likestructure as shown in FIGS. 2-14, to tubes having selected slot-shapedopenings, examples of which are shown in FIGS. 17A-22.

FIGS. 29A-29D show structure of another embodiment of an excisionaldevice according to one embodiment. As shown, the structure referencedby numeral 280 of FIG. 29A may replace die first helical elementdescribed above and may discharge, together with the proximal sheathshown at 284 in FIG. 29B, the tissue transport functionality. That is,the helical element 280, which may rotate independently of the workelement(s), urges the cored and severed specimen from the distal portionthereof to the transfer magazine 27. As shown, the helical element 280may be formed of a hollow tube in which one or more slot-shaped openingsor fenestrations 282 may be defined. Such fenestrations 282 may becontinuous or discontinuous, non-overlapping or overlapping. In theimplementation shown in FIG. 29A, a plurality of fenestrations 282(which may be laser-cut from the tube forming the proximal sheath), aredisposed in a generally spiral configuration. Other configurations arepossible.

FIG. 29B shows one embodiment of a proximal sheath 284 of an excisionaldevice according to one embodiment. The proximal sheath may discharge adual function of actuating the tendon actuating element 469 (ifconfigured as in FIG. 19) through differential motion thereof with thebody portion 428 (FIG. 19), as well as working in concert with thehelical element 289 to transport the cored and severed tissue samplesproximally toward the storage or transfer magazine 27. The proximalsheath 284 may be coupled to the body portion 428 and to the actuationelement 469 of the work element as shown, for example, in FIGS. 21 and22. As shown in FIG. 29B, the proximal sheath 284 may comprise one ormore slot-shaped (for example) fenestrations 286. In the implementationof FIG. 29B, the fenestrations are narrow slots that are disposed in aspiral pattern. These slots may be continuous or discontinuousoverlapping or non-overlapping, of uniform or non-uniform width.Fenestrations, slots or openings of different shapes are expresslyencompassed herein. As shown in FIG. 29B, the fenestrations 286 may bespirally-wound around the tube, and the direction of the resultingspiral pattern may be the same as that of the helical element 280.However, when the proximal, sheath 284 is fitted over at least a portionof the helical element 280, the respective spiral (or other)fenestration patterns may be crossed such that the fenestration patternin the helical element 280 cross the fenestration pattern in theproximal sheath 284 or not, depending on the relative axial positionbetween these two helical elements at any given time, as shown in FIG.29C.

According to one embodiment, effective tissue transport may be achievedwhen the right balance is achieved between the resistance to tissueadvancement as between the helical element 280 and inner wall of theproximal sheath 284. In order to promote the longitudinal (axial)movement of the cored and severed tissue sample within the helicalelement, stopping or greatly reducing the rotation of the sample may bebeneficial. As noted above, the proximal sheath 284, according to oneembodiment, is fitted over at least a portion of the helical element280, as shown end-on in FIG. 29D. FIG. 29D shows the annular space 288formed between the outer wall of the helical element 280 and the innerwall of the proximal sheath 284. According to one embodiment, a flushmay be incorporated in the annular space 288, or between the outersheath (which may actually take the form of either a distal sheath 590or an outer sheath 512 previously referred to in other figures, butreferred to collectively as 590, according to embodiments and as shownin this figure for simplicity) and inner sheaths, to father facilitatetissue transport. Moreover, a vacuum may be drawn within at least thehelical element, which may further facilitate tissue transport. Thisenables the user to collect any fluids to enhance cleanliness during theprocedure, to help with visualization and to collect cells for cytology.Moreover, according to one embodiment, such a flush pathway enables thedelivery of, for example, biologically active substances and/or markers.It should be noted that, according to embodiments, an inner helicalelement 280 may not be present while other embodiments, such as thoseusing a split tube long monolithic beak assembly, such as previouslydescribed in FIGS. 15A, 15B and 15C above, may only have two concentrictubes, which may be considered to be an outer sheath and the inner longbeak assembly.

Coupled with flush and vacuum, the fenestrations defined in the proximalsheath 284 and in the helical element 280 may enable a helical “pumping”feature and to create a reservoir of fluids surrounding the tissue,which may enable a swirling wave action to interact, with the cored andsevered tissue samples to gently push them in the proximal direction.The fenestrations in both the helical element 280 and the proximalsheath 284, as examples of such fenestrations or features, lessen therespective wall surface areas of these structures and thus decrease thesurface friction experienced by the cored and severed tissue sample,both of which (wall surface area and friction) impede transport. Suchstructures also exhibit a favorable “sealing” effect surrounding thetissues, particularly where irregular tissues might, based on their ownsurface architecture, engender vacuum leaks. Indeed, the gentle urgingof the cored and severed tissue samples preserves the underlying tissuearchitecture and delivers a clinically-useful sample (e.g., one whosetissue architecture has not been unacceptably damaged during itstransport) to the transfer magazine 27.

One embodiment, as discussed above and shown relative to FIGS. 29A-D,replaces the discrete, spring-like helical element with a tube 280having one or more slot-shaped fenestrations defined therein. Replacinga discrete helical element with the variant shown in FIG. 29A eliminatesa separate structure that otherwise would have been required to bothtransmit torque and provide differential forces in a longitudinaldirection for beak actuation. Moreover, eliminating a spring-likehelical member in favor of a unitary tube in which slot-shaped (forexample) fenestrations may be present reduces the parts count and easesmanufacturing of the device 10. The structure of FIG. 29D comprising theproximal sheath 284 fitted over at least a portion of the helicalelement 280 provides simplicity, robustness, increased actuationprecision, a decreased torque dram and less disruptions in thearchitecture of the transported tissue sample.

According to one embodiment, a thin outer sheath 590 may be disposedover at least a portion of the proximal sheath 284. The thin outersheath 590, according to one embodiment, may be configured to be non- ormanually rotating. According to one embodiment the outer sheath 590(shown in FIG. 29D) may be formed of or comprise, for example,polyimide.

According to another embodiment, and as shown in FIG. 20, the non- ordifferentially rotating distal sheath (not shown in this FIG. 29Dspecifically) may be configured to fit over the work element as shown inFIG. 19 comprising the body portion 428, the tendon actuating element469 and at least a portion of the first or first and (if present)articulable beaks. The outer sheath 590 may be configured to slide andfit over both the distal and the proximal sheath 584 that ismechanically coupled to the work element. In such an embodiment, theinner or first helical element may be deleted entirely, but the helicalslots previously shown in element 280 of FIG. 28A may be incorporatedinfo such distal sheath. The outer sheath 590, according to embodimentsmay cover the distal sheath to prevent or lessen tissue wind-up duringrotation. The outer sheath 590 may also create an annular space forflush to travel forward to its distal end, depositing flush,anesthetics, anticoagulants, vasoconstrictors and the like to the verydistal end of the work element; that is, to the beak or beaks and/or tothe scoopula-shaped distal end of the device. The outer sheath 590 mayfunction to protect the beak(s) of the work element during openingthereof, to prevent the beak(s) from experiencing too greatstrangulation forces, as the beak(s) of the work element may be causedto move slightly proximally dining beak opening, such that the beaksopen (for the most part) under the shelter provided by the outer sheath590. The thin (e.g., polyimide or thin hypotube) outer sheath alsoprotects the tendons and the living hinge areas of the work element aswell as the distal portions of the beak or beaks by removing some of therotational resistance. Moreover, such outer sheath 590 may also providecover and protection for at least part of the distal sheath and proximalsheath 284 that does not flex inward with the living hinge and workelements, such that these do not snag tissues during forward excursionwithin tissue. Lastly, a polyimide or other material outer sheath 590may have a naturally or coated lubricious surface that is highlyimpervious to chemicals that the excisional device is likely toencounter and can readily be sterilized.

FIGS. 30A and 30B show another embodiment of a work element, accordingto one embodiment. Specifically, the work element 13 in FIG. 30A issimilar to that shown in FIGS. 21 and 22 (although two beaks are shownin FIG. 30A). Attention is drawn to the proximal end of the work element13. Therein, the body portion 428 of the work element 13 may bemechanically coupled to the tendon actuating element 469 at the proximalend of the work element. Note that the tendon actuating element 469,from the embodiment of FIGS. 21 and 22, is already coupled to the bodyportion 428 through the tendons 468, 470, toward the distal end of thework element 13. That is, the entire work element 13 may be formed of asingle homogeneous material—such as from a single hollow tube that is(for example) laser-cut to form the structures shown in FIGS. 30A and30B. Two beaks are shown. It is to be understood, however, that suchneed not be the case, as the work element 13 may comprise multiple beaksor a single beak that acts against a non-moveable part, such as a fixedtrough-shaped or scoopula-shaped distal portion of an outer sheath, suchas element 512 from FIGS. 15A and 15B above.

According to one embodiment, as shown in FIGS. 30A and 30B, the proximalend of the tendon actuating element 469 may be mechanically coupled tothe proximal portion of the body portion 428. Such mechanical couplingmay be configured to maintain the tendon actuating element centered onthe cutout in the body portion formed to accommodate the tendonactuating element 469 and/or to provide additional biasing force in thedistal direction, as well as to aid in manufacturing. One embodimentcomprises a resilient member 427 having one end thereof coupled to thetendon actuating element 469 and another end thereof coupled to theproximal portion of the work element 13. Such a resilient member 427 maybe configured to bias the beak or beaks of the work element 13 in theopen configuration, such that a sufficiently great proximally-directedforce applied to the tendon actuating element 469 tends to close thebeak or beaks. Conversely, release of such proximally-directed forcecauses the resilient member 427 to release the energy stored during theextension thereof and return to its un-extended state, thereby exertinga distally-directed force on the tendon actuating member 469, whichcauses the beak or beaks to return to its or their default openconfiguration.

Also shown in FIG. 30B, attachment holes 292A and 292B may be providedon the body portion 428 and on the tendon actuating element 469,respectively. Such attachment holes 292 may, according to oneembodiment, indicate the location of, for example, spot welds, asdetailed below.

FIG. 31 shows a distal portion of a proximal sheath according to oneembodiment. The proximal sheath 300, as shown in FIG. 31 may comprise anumber of fenestrations or slots 304 that run through the wall of theproximal sheath 300, from an outer surface to the interior lumenthereof. The distal portion of the proximal sheath 300 may be configuredto fit over and attach to the proximal end of the monolithic beakassembly 13 of FIGS. 30A and 30B. During assembly of the presentexcisional device and as shown in FIG. 32, the attachment holes 308A and308B of the proximal sheath 300 may be lined up with the attachmentholes 292A and 292B, respectively, of the monolithic beak assembly 13and the proximal sheath 300 attached, to the monolithic beak assembly 13at attachment points 292A, 308A and 292B, 308B. According to oneimplementation, the attachment point 308A of the proximal sheath 300 maybe spot-welded to the attachment point 292A of the tendon actuatingmember 469 of the monolithic beak assembly 13. Although not shown inthese figures, corresponding attachment points may be provided on thehidden side of the device. Similarly, the attachment point 308B of theproximal sheath 300 may be spot-welded to the attachment point 292B ofthe body portion 428 of the monolithic beak assembly 13. As also shown,in FIG. 31, the distal portion of the proximal sheath 300 may define aresilient or spring portion, as shown at reference numeral 306.

FIG. 33 shows the distal portion of a distal sheath 320, according toone embodiment. The distal sheath 320 may be configured to fit over theproximal sheath 300 and the attachment point 326 of the distal sheath320 attached to attachment point 310 on the proximal sheath 300, asshown in FIGS. 32 and 34. For example, the attachment point 326 of thedistal sheath 322 may be spot-welded to attachment point 310 on theproximal sheath 300, as suggested in FIG. 34. The distal sheath 320 istransparently illustrated in FIG. 34, to show underlying detail. It isto be understood that spot-welding is but one method of attaching theconstituent components of the present excisional device to one another.Other attachment technologies may also be used, as appropriate. Once thedistal sheath 320 is spot welded in place, it will rotate insynchronicity with the beak assembly 13 and proximal sheath 300, butwill be able to move axially relative to proximal sheath 300. Such axialmovement between the distal and proximal sheaths will positively openand/or close the beak or beaks of monolithic beak assembly 13, aspreviously discussed.

FIG. 35 shows one embodiment of the present excisional device, in astill further intermediate state of assembly. In FIG. 35, an outersheath 330 has been fitted over the assembly comprising the monolithicbeak assembly 13, the proximal sheath 300 and the distal sheath 320, andfor purposes of illustration, without the scoopula shaped extremity thatwould be formed in the continuation of the outer sheath, in order toshow the beaks 13 easily. For example, the outer sheath 330 may comprisepolyimide or may comprise or be formed of stainless steel. The outersheath 330 may be configured to be manually rotating, non-rotating, orat least differentially rotating with respect to the assembly comprisingthe monolithic beak assembly 13, the proximal sheath 300 and the distalsheath 320. That is, while the assembly comprising the assemblymonolithic beak assembly 13, the proximal sheath 300 and the distalsheath 320 may rotate, at relatively high rates of speed (in thethousands of revolutions per minute, for example), the outer sheath 330may be held stationary or rotated as needed, either manually orotherwise actuated by any mechanical means. For example, the user mayrotate the outer sheath 330 a few tens of degrees at a time, as and whenthe procedure requires, for example in sampling around the clock aspreviously described. The outer sheath 330 may extend distally to thebeaks of the monolithic beak assembly 13, may expose a greaterproportion of the monolithic beak assembly 13 or may cover a significantportion of the beaks. According to one embodiment, one “side” of theouter sheath 330 may form a trough or scoopula shape and extend at leastslightly beyond the distal-most tip of the beak or beaks of themonolithic beak assembly 13. Indeed, the embodiment shown and describedrelative to FIGS. 29A through 33 may comprise a single beak or two ormore beaks.

According to one embodiment, the outer sheath 330 may be dimensioned soas to allow an annular space to exist between the outer surface of thedistal sheath, the distal portion of the monolithic beak assembly 13along with the distal sheath 320 and the inner wall of the outer sheath330. This annular space allows for flush to be introduced at selectedstages in the procedure. The flush may provide lubrication for therotation of the assembly comprising the assembly monolithic beakassembly 13, the proximal sheath 300 and the distal sheath 320 and mayfacilitate the rotation and thus the transport of the cored and severedtissue specimen in the distal direction. According to one embodiment,when the beak or beaks of the monolithic beak assembly is or are in theopen configuration, the fenestrations or slots 304 (FIG. 31) defined inthe proximal sheath 300 are not lined up with the fenestrations or slots324 (FIG. 33) defined in the distal sheath 320. However, according toone embodiment, when the beak or beaks are actuated, and the beaks areclosing, are closed or are substantially closed, the fenestrations orslots 324 defined in the distal sheath 320 become or are lined up orsubstantially lined up with corresponding one or ones of thefenestrations or slots 304 defined in the proximal sheath 300. In thisstate, if there is flush in the annular space between the outer surfaceof the distal sheath 320 and the inner wall of the outer sheath 330,this flush will enter the interior lumen of the device (where the coredand severed tissue specimens are collected and are transported).Moreover, as the flush may have been entrained info rotation in theaforementioned annular space as the assembly comprising the monolithicbeak assembly 13, the proximal sheath 300 and the distal sheath 320rotates, the rotating flush may enter this interior lumen with someforce and may exert that force on any cored and severed tissue specimentherein. This flush may act as a lubricant as well, to the specimencontained in the inner lumen of the device. According to one embodiment,a vacuum may be drawn within the interior lumen of the device. Accordingto one embodiment, the force imparted on the cored and severed tissuespecimen, together with the force imparted on such specimen by the flushentering this interior lumen, draws and transports the cored and severedtissue specimen in the proximal direction, for eventual transport to thetransfer magazine 27, for example.

Transport may be aided by the shoulder shown at 332 in FIG. 35. Indeed,this shoulder encompasses the location defined by the proximal end ofthe monolithic beak assembly 13 and the distal end of the proximalsheath 300. As the diameter of the proximal sheath 300 is somewhatgreater than that of the proximal end of the monolithic beak assembly13, the interior lumen of the proximal sheath 300 is correspondinglygreater than the interior lumen of the monolithic beak assembly 13. Asthe cored and severed tissue specimen enter the interior lumen of themonolithic beak assembly 13, they may be somewhat compressed. Suchcompression may be somewhat relieved as the tissue specimens transitionfrom the lumen of the monolithic beak assembly 13 to the lumen ofsomewhat greater diameter of the proximal sheath 300, at shoulder 332.This decompression of the tissue specimen in the lumen of the proximalsheath 300 may, together with the flush and the vacuum, also facilitatetissue transport. The shoulder at 332 could expand the inner lumendiameter in the range of 0.001 inch to 0.100 inch additional over theoriginal lumen internal diameter or double the lumen internal diameter,whichever is greater. As previously mentioned, shoulder features may beincorporated into the proximal sheath, distal sheath and outer sheath toaugment such tissue expansion/transport action.

FIG. 36 is a flowchart of a method according to one embodiment. As showntherein, block B361 calls for providing a device. According to oneembodiment, the provided device may comprise an outer sheath and aninner assembly configured to be received (at least partially) within theouter sheath. The outer sheath may define a diameter, a longitudinalaxis, a proximal portion and may comprise a fixed distal scoop ortrough-shaped open portion. The inner assembly may define a proximalportion, a distal portion and a body portion between the proximal anddistal portions. According to one embodiment, the distal portion maycomprise an articulable beak element configured to core through and cuttissue. Block B362, as shown, calls for inserting the fixed distalscoop-shaped open portion of the biopsy device into tissue through anincision, with the articulable beak element(s) in a closed configurationrelative to the fixed distal scoop-shaped open portion. As shown atB363, if not already open, the articulable beak element may be openedrelative to the fixed distal scoop-shaped open portion and a step ofcoring through the tissue may be carried out. According to oneembodiment, the articulable beak element may be rotating during all orpart of the coring. The articulable beak element may then be closed andthe cored tissue may be parted-off against the fixed distal scoop-shapedopen portion, as shown at B364. The articulable beak element may berotating during the parting-off. As previously described, the parted-offcored tissue may then be transported in the proximal direction withinthe inner assembly.

FIG. 37 is a flowchart of a method of positioning a biopsy device,according to one embodiment. As shown therein. Block B371 calls forcoupling a biopsy device to a stereotactic biopsy device assemblycomprising at least one capstan assembly. One embodiment of a suitablecapstan is shown in FIGS. 27A-C and FIGS. 28A-D. The stereotactic biopsydevice assembly may be configured to couple to a stage of a stereotactictable. According to one embodiment the stereotactic biopsy deviceassembly may comprise a first portion configured to fixedly couple tothe stage and a second portion movably coupled to the first portion. Afirst capstan assembly may be configured to couple to the second portionof the platform and to the biopsy device. Block B372 calls for thebiopsy device to enter the tissue along the z-axis, whereupon a tissuesample may be obtained, as shown at B373. The capstan assembly may thenbe operated, as shown at B374. For example, a ship's wheel (or othertype of actuator) of the capstan assembly may be turned or otherwiseactuated, either manually or by machine using either Cartesian or polarcoordinates, within the degrees of freedom allowed by the capstanassembly. The capstan assembly may be operated entirely manually,controlled by the user using his or her best clinical judgment, andskill, optionally raider direct visualization. The position of thebiopsy device in the x-y plane within the tissue may then be changed(changing the angle of attack of the biopsy device) as the capstanassembly or assemblies is/are operated, as shown at B375. For example,capstan assemblies may be used to identically or differentially raise orlower the distal and/or proximal ends of the biopsy device and to movethe biopsy to a position that is off-center relative to its initialposition. The biopsy device may also be rotated in conjunction with themovement imparted thereto by the capstan assembly or assemblies coupledthereto.

FIG. 38 is a flowchart of another method according to one embodiment. Asshown in FIG. 38, Block B381 calls for inserting a biopsy device throughan incision in tissue. According to one embodiment, the inserted biopsydevice may comprise an outer element comprising an open scoopula-shapeddistal portion having a sharpened edge, and an inner assembly configuredto fit at least partially within the outer element and comprising atissue coring and parting off assembly. As shown at B382, the biopsydevice may then be advanced within the tissue to the intended biopsysite. B383 calls for coring and parting off the tissue to cut a firsttissue specimen from the biopsy site. At least the outer element may berotated as shown at B384, while the sharpened edge of the openscoopula-shaped distal portion cuts through an arc of tissue. Accordingto one embodiment, the arc of tissue may be oriented substantiallynormal to the long axis of the tissue specimen. That is, according toone embodiment, the open scoopula-shaped distal portion may be rotatedabout its longitudinal axis (e.g., 14 in FIG. 15B), which is normal tothe long axis of the tissue specimen (shaped like, according to oneembodiment, short segments of a tube, with tapered proximal and distalends). After rotating, one or more further tissue specimens may be cutfrom the tissue facing the open scoopula-shaped distal portion, whichfacing tissue may be radially separated from the tissue from which theprevious, pre-rotation specimen was cut.

According to one embodiment, the inserting in Block B381 may be carriedout with the tissue coring and part-off assembly comprising at least onearticulated beak element. Coring and parting off, rotating andgenerating steps may be repeated as desired to generate tissue specimensat least partially “around the clock”; that is, at least partially about360 degrees of rotation. Hie tissue may be caused to prolapse or toprolapse further into the open scoopula-shaped distal portion after therotating step of Block B384. Such may be carried out by, for example,imposing an axially-directed movement on the biopsy device before orafter the rotating step. The cut specimen(s) may then be transportedwithin the biopsy device away from the biopsy site. Advancing the biopsydevice within the tissue in Block B382 may cause the sharpened edge ofthe open scoopula-shaped distal portion to dissect tissue along aninsertion path. According to one embodiment as the coring and part-offassembly is advanced such that the distal tip thereof faces the distaltip of the open scoopula-shaped distal portion, the coring and partingoff of the tissue may be carried, out with substantially zero dead spaceat the distal tip of the biopsy device. Conversely, the tissue coringand parting off assembly may be retracted away from the distal tip andsharpened edge of the open scoopula-shaped distal portion during theadvancing and/or rotating steps or for such purposes as parting off aspecimen that is less than the fell length of the scoopula, as well asother purposes. Such advancing, retracting and rotating steps may becarried out stereotactically or may be controlled or carried outmanually by the user of the biopsy device. The sharpened edge of theopen scoopula-shaped distal portion may be configured to cut at an anglethat, is substantially normal (i.e., substantially perpendicular) to along axis of the specimens (generally tapered tube-shaped pieces oftissue) cut and collected by the biopsy device.

As shown in the figures and as noted above, the proximal sheath 300,according to one embodiment, may be attached to the body portion 428 aswell as to the tendon actuating portion 469 of the monolithic beakassembly 13. In turn, the distal sheath 320 may be attached to theproximal sheath 300 at attachment point 326. In this manner, rotation ofthe distal sheath will entrain the monolithic beak assembly and theproximal sheath 300 in rotation also or vice versa, depending on thedriving mechanism of such embodiments. Therefore, according to oneembodiment, the rotation for tissue specimen transport is the same asthe rotation for specimen collection using the monolithic beak assembly.Moreover, since the interior lumen of the proximal sheath 300 may berelatively smooth and as the interior lumen thereof may be furtherlubricated with flush entering the lumen through aligned fenestrations304, 324 in the proximal sheath 300 and the distal sheath 320, thetissue specimen may be transported substantially intact (e.g., with thetissue architecture undamaged or not damaged to such a degree as tohinder examination) to the transfer magazine 27 or to the proximal endof the interior lumen.

According to one embodiment, as attachment points 326 of the distalsheath 320 are attached to corresponding attachment points 310 onproximal sheath 300, which are attached to the tendon actuating members469, a distally-directed force applied to the proximal sheath 300 actsto close the beak or beaks of the monolithic beak assembly 13. This isbecause the tendon actuating members 469 are acted upon by the axiallystationary distal sheath 320, while the body portion of the monolithicbeak assembly 13 is held by the proximal sheath 302, at attachmentpoints 308B, 292B and moved axially forward, causing the beaks to closedown via their living hinges. The spring or resilient portions 427 onthe monolithic beak assembly 13, the spring or resilient portion of theproximal sheath 362 act in concert, to bias the beak or beaks in tireopen configuration such that, when the distally-directed force impartedon the proximal sheath 300 is released, the beak or beaks of themonolithic beak assembly 13 return to their default open configuration.It should be noted that holding the proximal sheath stationary axiallywhile exerting a proximal force on the distal sheath will produce anidentical beak open/closing mechanism, and may be selected to match witha driving mechanism that will accommodate such action, as may beenvisioned by one skilled in the art.

Significantly, the coring and transport mechanisms and methods describedand shown herein are configured to apply traction while coring, as thebeak(s) either close against the scoopula, if one beak is used, oragainst each other if dual beaks are used and are then withdrawn to itsor their resting position within the proximal edge of the scoopulaopening, carrying the tissue specimen wife it or them. That is, coring,cutting, parting-off, traction and transport may be, according to oneembodiment, carried out simultaneously, in so doing, as traction isapplied during a cutting event, the cutting event is not only renderedmore efficient but may be the only way to successfully cut certaintissue types. This traction, according to one embodiment, is facilitatedby the continuous interaction of the helical element(s), the tubularcoring and transport assembly, and the flush and aspiration, dependingon embodiments, which all or separately act together to provide gentlecontinuous traction beginning immediately upon the tissue entering thelumen of the tubular coring and transport assembly 11 of FIG. 1 andcontinuing during part-off of the tissue specimen. According to oneembodiment, the ratio between the twisting and pulling actions may becarefully controlled by, for example, control of rotation versus crankor cam speed, or other axial control mechanism. According to oneembodiment, when the beak assembly is open wider than the inner lumen ofthe tubular coring and transport assembly, tissue is drawn in by atleast the surface treatments), channels, and helical, elements past thesharp beak assembly and into, the inferior, lumen of the tubular coringand transport assembly. This may be, according to one embodiment,augmented with either flush or vacuum or both. However, it is to benoted that the transport mechanisms and functionality described hereinis more effective than vacuum alone, as vacuum predominantly actslocally at the proximal surface of a specimen. Indeed, the transportmechanisms described and shown herein (e.g., surface treatments,rifling, vacuum slots, helical element(s), and the selective rotation ofthese) may be configured to act along the entire length of the sidewallsof the tissue specimen, which may be useful in transporting certaintissue types. Vacuum, according to one embodiment, may well augment suchtraction and transport but need not be the primary modality by whichtissue specimen are drawn proximally or materials are pushed distally tothe target lesion site. According to one embodiment vacuum may be usedfor extracting cells, body fluids and flush fluids, and to prevent theinadvertent injection of outside air, which may obscure an ultrasoundimage or transfer other unwanted elements into the body.

The present, biopsy device may be formed of or comprise one or morebiocompatible materials such as, for example, stainless steel or otherbiocompatible alloys, and may be made of, comprise or be coated withpolymers, such as polyimide, and/or biopolymer materials as needed tooptimize function(s). For example, the cutting elements (such as theconstituent elements of the beak assembly 13) may comprise or be made ofhardened alloys and may be additionally coated with a slippery materialor materials to thereby optimize passage through living tissues of avariety of consistencies and frictions. Some of the components may bepurposely surface-treated differentially with respect to adjacentcomponents, as detailed herein in reference to the transporting tubularand storage components. The various gears or pulleys may be made of anysuitable, commercially available materials such as nylons, polymers suchas moldable plastics, and others. If used, the motor powering thevarious powered functions of the present biopsy device may be acommercially available electric DC motor. The handle of the presentbiopsy device may likewise be made of or comprise inexpensive,injection-molded plastic or other suitable rigid, easily hand heldstrong and light-weight material. The handle may be configured in such away as to make it easily adaptable to one of any number of existingguiding platforms, such as stereotactic table stages. The materials usedin the present, biopsy device may also be carefully selected from aferro-magnetic standpoint, such that the present biopsy device maintainscompatibility with MRI equipment that is commonly used for biopsyprocedures. The vacuum/delivery assembly components may comprisecommercially available vacuum pumps, syringes and tubing for connectingto the present biopsy device, along with readily available reed valvesfor switching between suction and emptying of materials such as fluids,which may be suctioned by the vacuum components. The fluids collected bythe embodiments of the present biopsy device in this manner may then beejected into an additional external, yet portable, liquid storage vesselconnected to the tubing of the present biopsy device, for discarding orfor safe keeping for laboratory cellular analysis.

The power source, may comprise an external commercially available AC toDC transformer approved for medical device use and plugged into theprovided socket in the present biopsy device, or may comprise anenclosed battery of any suitable and commercially available powersource. The battery may be of the one-time use disposable (andoptionally recyclable) variety, or may be of the rechargeable variety.Additionally, other power sources, for example, mechanical linkages orcompressed air motors, may be used.

The cutting beak assembly of embodiments of the biopsy devices may beused, without alteration of then shape, attachment or any othermodification, to penetrate tissue on approach to a target lesion. Thecutting beak assembly may then be used to open and core the tissuespecimen, and to thereafter part-off the specimen at the end of thecoring stage. The beak assembly may also be used to help augmenttransport of the collected specimen. Having such multiple functionsintegrated in a single device saves valuable cross-sectional area, whichin rum creates a device that has a minimal outer diameter whileproviding the maximum diameter core sample. Maximizing the diameter ofthe core sample is believed to be significant from a clinicalstandpoint, since it has been demonstrated in multiple peer-reviewedjournals that, larger diameter core specimens yield more accuratediagnoses. The clinical desire for large diameter core samples, however,must be balanced against the trauma associated with larger caliberdevices. Embodiments optimize the ratio so that, the clinician can havethe best of both worlds.

Advantageously, according to one embodiment, an internal helicaltransport system may be configured to augment the coring function of theforward cutting beaks. The helical transport coring elements may beconfigured to apply gentle, predictable traction on the cored specimen,during and after coring, which permits pairing the ideal speed oflongitudinal excursion of the coring elements of the present biopsydevice with the ideal speed of rotational movement, of the sameelements. In this manner, the architecture of the collected specimen isless likely to be disrupted during transport. It has been shown inpeer-reviewed scientific articles that preserving tissue architecture(i.e., preserving the architecture of the tissue as it was in vivo) tothe extent possible leads to an easier and more accurate diagnosis. Thepresent vacuum/delivery mechanism may be configured to enable the forceof vacuum to be exerted directly to the coring transport components,such that coring and transport of the specimen is handled as delicately,yet as surely, as possible and comprises non-significantlydimension-increasing components such as progressively sized fenestrationfeatures within collection magazine areas. If the present biopsy devicewere to rely solely on vacuum for tissue transport then vacuum artifact,which is a known and described phenomenon associated with conventionalbiopsy devices, might be present to a greater degree than is present (ifat all) in embodiments described herein. On the other hand, wereembodiments of the present biopsy device to rely solely on a physicalpushing or pulling mechanism to retrieve cut specimen samples, crushartifact might be more prominent than is otherwise present whenembodiments of the present biopsy device and methods are used.

The internal surface treatments of an outer tube and a hollow, helicalinner component, when acting in conceit, move materials in a variety ofphase states along longitudinally without the need for complexcomponents that would otherwise contribute substantially to the outercaliber dimensions of the present biopsy device. Embodiments comprise ahollow helical transport mechanism that may be both strong and flexible,which continues to function even when distorted by bending. Conventionalbiopsy devices typically cease to function properly if distorted evenslightly. As such, the present biopsy device may be configured to definea curve along its longitudinal axis and would still function properly,with minimal modifications.

Advantageously, a biopsy and coring device, according to embodiments,comprises features configured to perform medical core biopsy proceduresor for shaping (such as for vascular applications) or harvesting tissuefor other uses. These features comprise structures configured forpenetration, coring, part-off, transport and storage of core specimensfor medical purposes such as diagnosis and treatment of a variety ofdiseases and abnormalities. Integral and detachable components may beprovided and configured to aspirate fluids for cellular analysis as wellas deliver agents at various selectable stages of the procedure. Thepresent biopsy device may be selectable for automatic and/orsemi-automatic function, may be used with or without image guidance, andmay be compatible with a variety of guidance imaging equipment such asultrasound, magnetic resonance imaging and X-ray imaging. The presentbiopsy device may be configured to be disposable and/or recyclable,highly portable, and delivered for use in sterile packaging, typical ofmedical devices having contact with internal body structures. Thepresent biopsy device may be configured to be minimally invasive. Asembodied herein, the present biopsy device comprises several featuresthat may be therapeutic in nature, to be utilized at various stagesalong the diagnosis/treatment pathway.

While certain embodiments of the disclosure have been described, theseembodiments have been presented by way of example only, and are notintended to limit the scope of the disclosure. Indeed, the novelmethods, devices and systems described herein may be embodied in avariety of other forms and other applications. For instance, themonolithic beak structures with living hinges, tendon actuationmechanisms and attached actuating sheaths and other mechanisms describedherein may find use on a different scale for such applications, such asrobotic arm manipulation and collection systems, so that such a roboticarm would be capable of picking up an object or material, if desired. Asanother example, the cam and cam follower configurations described inFIGS. 23-26A may find applications such as for internal combustionengine valve configurations, wherein an overhead cam of a special shapeacts on a valve stem or extension of a valve stem for instance a domedor other shape. Following the discussion outlined in these lastreferenced figures, it may be seen that the valves on an internalcombustion engine may be extremely finely tuned with respect to dynamicssuch as initial or staged acceleration/deceleration during opening andclosing of the valves. All such other applications making use of theprinciples disclosed herein for this device and that could be envisionedby one skilled in the art are therefore considered to be within thescope of this disclosure. Furthermore, various omissions, substitutionsand changes in the form of the methods and systems described herein maybe made without departing from the spirit of the disclosure. Theaccompanying claims and their equivalents are intended to cover suchforms or modifications as would fall within the scope and spirit of thedisclosure. For example, those skilled in the art will appreciate thatin various embodiments, the actual physical and logical structures anddimensions thereof may differ from those shown in the figures. Dependingon the embodiment, certain steps described in the example above may beremoved, others may be added. Also, the features and attributes of thespecific embodiments disclosed above may be combined in different waysto form additional embodiments, all of which fall within the scope ofthe present disclosure. Although the present disclosure provides certainpreferred embodiments and applications, other embodiments that areapparent to those of ordinary skill in the art, including embodimentswhich do not provide all of the features and advantages set form herein,are also within the scope of this disclosure. Accordingly, the scope ofthe present disclosure is intended to be defined only by reference tothe appended claims.

1-65. (canceled)
 66. A stereotactic biopsy device assembly, comprising:a platform configured to couple to a stage of a stereotactic table, theplatform comprising a first portion configured to fixedly couple to thestage and a second portion movably coupled to the first portion; a firstcapstan assembly, the first capstan assembly being configured to coupleto the first and second portions of the platform and to a biopsy deviceconfigured to enter tissue along a z-axis, the capstan assembly beingformer configured to enable a position of the biopsy device in an x-yplane to be gradually changed.
 67. The stereotactic biopsy deviceassembly of claim 66, wherein the first capstan assembly comprises anactuator configured to be rotated about a central axis, wherein rotationof the actuator causes the position of the biopsy device in die x-yplane to change.
 68. The stereotactic biopsy device assembly of claim66, wherein the first capstan assembly is further configured togradually move the biopsy device away from an initial position when theactuator is turned.
 69. The stereotactic biopsy device assembly of claim67, wherein the first capstan assembly defines a pathway that spiralsfrom a first location close to an axis of the actuator to a secondlocation away from the axis of the actuator, the spiral pathway causingthe biopsy device to gradually move from an initial position in the x-yplane to a final position in the x-y plane as the actuator is rotated.70. The stereotactic biopsy device assembly of claim 66, wherein thefirst capstan assembly is configured to be coupled to a proximal end ofthe biopsy device.
 71. The stereotactic biopsy device assembly of claim70, further comprising a second capstan assembly coupled to a distal endof biopsy device.
 72. The stereotactic biopsy device assembly of claim71, wherein the first capstan assembly is independent of the secondcapstan assembly.
 73. The stereotactic biopsy device assembly of claim71, wherein differential operation of the first and second capstanassemblies changes an angle of attack of the biopsy device.
 74. A methodof positioning a biopsy device, comprising: coupling the biopsy deviceto a stereotactic biopsy device assembly configured to couple to a stageof a stereotactic table, the stereotactic biopsy device assemblycomprising; a first portion configured to fixedly couple to the stageand a second portion movably coupled to the first portion, and a firstcapstan assembly, the first capstan assembly being configured to coupleto the first and second portions; entering, tissue along a z-axis;obtaining a tissue sample; operating the first capstan assembly, andchanging a position of the biopsy device in an x-y plane within thetissue as the first capstan assembly is operated.
 75. The method ofclaim 74, wherein the first capstan assembly comprises an actuatorconfigured to be rotated about a central axis, and wherein operating thefirst capstan assembly comprises rotating the actuator about the centralaxis to change the position, of the biopsy device in the x-y plane. 76.The method of claim 75, wherein operating the first capstan assemblycomprises gradually moving the biopsy device away from an initialposition when the actuator is turned.
 77. The method of claim 75,wherein the first capstan assembly defines a pathway that spirals from afirst location close to an axis of the actuator to a second locationaway from the axis of the actuator, and wherein operating comprisescausing the biopsy device to gradually move along the spiral pathwayfrom, an initial position in the x-y plane to a final position in thex-y plane.
 78. The method of claim 74, wherein coupling comprisescoupling the first capstan assembly to a proximal end of the biopsydevice.
 79. The method of claim 74, wherein the stereotactic biopsydevice assembly further comprises a second capstan assembly and whereincoupling comprises coupling the second capstan assembly to a distal endof the biopsy device.
 80. The method of claim 79, further comprisingoperating the second capstan assembly independently of the first capstanassembly.
 81. The method of claim 79, further comprising changing anangle of attack of the biopsy device by differentially operating thefirst and second capstan assemblies. 82-122. (canceled)
 123. A devicefor positioning a biopsy device, the device comprising a capstanconfigured to be coupled to a stage of a stereotactic table and to thebiopsy device, the capstan comprising: a surface defining an eccentricpath; a guide engaged in the eccentric path; and a rotatable actuator,wherein rotation of the rotatable actuator causes the guide to travelwithin the eccentric path to thereby change an orientation of the biopsydevice.
 124. The device of claim 123, wherein the surface is configuredsuch that the eccentric path generally forms a spiral.
 125. The deviceof claim 123, wherein the rotatable actuator, in a first position, isco-axially disposed relative to the biopsy device and offset, therefromin a second position.
 126. The device of claim 123, wherein therotatable actuator is configured for manual actuation.
 127. The deviceof claim 123, wherein the rotatable actuator is configured for machineactuation.